Category Archives: Depression

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Ketamine-like depression treatment on track for FDA approval

 

Ketamine offers lifeline for people with severe depression, suicidal thoughtsThe drug is a close relative of ketamine, a powerful medication used in hospitals primarily as an anesthetic; recent scientific studies have also shown its potential with treatment-resistant depression and suicidal ideation. Ketamine is also used recreationally — and illegally — as a club drug known as Special K. It generates an intense high and dissociative effects.Esketamine, which is not FDA-approved for any conditions, targets a different brain pathway than approved antidepressants, many of which have been around for decades. It is expected to be used in combination with antidepressants, but the latter can take a month or two to take effect. Esketamine, on the other hand, might have an effect within hours or days, according to an FDA briefing document.The drug was designated as a breakthrough therapy in 2013, intending to “expedite the development and review of drugs for serious or life-threatening conditions,” the FDA says. First-line treatments don’t work for roughly 30% to 40% of patients with major depressive disorder, according to the briefing document.The FDA does not have to follow the recommendation of advisory committees, though it often does.

ERs 'flooded' with mentally ill patients with no place else to turn

ERs ‘flooded’ with mentally ill patients with no place else to turnHowever, the research behind esketamine has come under some criticism, with two of five key studies failing to meet their primary endpoints. Only one of these studies is a positive short-term trial, whereas most FDA-approved antidepressants are backed by at least two, according to the briefing document. But Janssen has maintained that the overall picture is positive.Adverse events tended to occur in the first two hours patients received the drug, including sedation, blood pressure increases and dissociation. For this reason, patients wouldn’t be able to pick it up at a local pharmacy; it would be given under the supervision of health care professionals who can keep an eye on the person during those first two hours.Because of the drug’s close relationship to ketamine, experts have also raised concerns about its potential for misuse and abuse. The clinical trials have not seen evidence of this risk, according to presentations made during the meeting.Advisory panelists also expressed concern that not enough long-term data was available to characterize the drug’s cognitive effects and other health impacts down the line.Get CNN Health’s weekly newsletter

There were six deaths of patients taking esketamine in trials, including three suicides, but FDA materials concluded “it is difficult to consider these deaths as drug-related.”The only current FDA-approved medication for treatment-resistant depression combines two other drugs already on the market. Other non-pharmaceutical treatments exist, such as electroconvulsive therapy.Janssen spokesman Greg Panico said no information about pricing would be available at this time. An FDA decision is expected in early March, he added.

 

CNN)A ketamine-like drug for treatment-resistant depression was backed by a US Food and Drug Administration advisory committee on Tuesday. If it is then approved by the FDA, the drug — called esketamine — may provide a new option for patients with major depressive disorder who have tried at least two other antidepressants without success.A panel of experts voted to endorse the drug, which is made in nasal spray form by the pharmaceutical company Janssen, a division of Johnson & Johnson. Fourteen members voted that the benefits outweighed the risk, with two opposed and one abstaining.

Ketamine offers lifeline for people with severe depression, suicidal thoughts
703-844-0184 | NOVA Health Recovery | Alexandria, Va 22306

Ketamine offers lifeline for people with severe depression, suicidal thoughtsThe drug is a close relative of ketamine, a powerful medication used in hospitals primarily as an anesthetic; recent scientific studies have also shown its potential with treatment-resistant depression and suicidal ideation. Ketamine is also used recreationally — and illegally — as a club drug known as Special K. It generates an intense high and dissociative effects.Esketamine, which is not FDA-approved for any conditions, targets a different brain pathway than approved antidepressants, many of which have been around for decades. It is expected to be used in combination with antidepressants, but the latter can take a month or two to take effect. Esketamine, on the other hand, might have an effect within hours or days, according to an FDA briefing document.The drug was designated as a breakthrough therapy in 2013, intending to “expedite the development and review of drugs for serious or life-threatening conditions,” the FDA says. First-line treatments don’t work for roughly 30% to 40% of patients with major depressive disorder, according to the briefing document.The FDA does not have to follow the recommendation of advisory committees, though it often does.

ERs 'flooded' with mentally ill patients with no place else to turn

ERs ‘flooded’ with mentally ill patients with no place else to turnHowever, the research behind esketamine has come under some criticism, with two of five key studies failing to meet their primary endpoints. Only one of these studies is a positive short-term trial, whereas most FDA-approved antidepressants are backed by at least two, according to the briefing document. But Janssen has maintained that the overall picture is positive.Adverse events tended to occur in the first two hours patients received the drug, including sedation, blood pressure increases and dissociation. For this reason, patients wouldn’t be able to pick it up at a local pharmacy; it would be given under the supervision of health care professionals who can keep an eye on the person during those first two hours.Because of the drug’s close relationship to ketamine, experts have also raised concerns about its potential for misuse and abuse. The clinical trials have not seen evidence of this risk, according to presentations made during the meeting.Advisory panelists also expressed concern that not enough long-term data was available to characterize the drug’s cognitive effects and other health impacts down the line.Get CNN Health’s weekly newsletter

There were six deaths of patients taking esketamine in trials, including three suicides, but FDA materials concluded “it is difficult to consider these deaths as drug-related.”The only current FDA-approved medication for treatment-resistant depression combines two other drugs already on the market. Other non-pharmaceutical treatments exist, such as electroconvulsive therapy.Janssen spokesman Greg Panico said no information about pricing would be available at this time. An FDA decision is expected in early March, he added.

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Is Ketamine Safe and Effective for Depression?

The anesthetic ketamine, used in both humans and animals, is perhaps best known as an illegal party drug due to its hallucinogenic effects. However, a growing body of research indicates that the drug may have a powerful new medical use: as a fast-acting antidepressant without the side effects seen in most prescription antidepressants.

As Nature reports, in many clinical trials to date people who have not responded to standard antidepressant treatment — such as SSRIs including Prozac — seem to respond to ketamine. And while it can take weeks to feel better after starting a prescription antidepressant, the therapeutic effects of ketamine are seen in a matter of hours.

Despite the seemingly “miracle drug” nature of ketamine, there are serious concerns about its use in depression. First, it is unclear how the drug works to alleviate depression. Second, there are no long-term studies on its long-term use. Studies that have already been done indicate the antidepressant effects of ketamine can last from between a few days to a few weeks.

And due to the addictive nature of ketamine itself, there are worries that sustained use of it may lead to dependence.

On May 4, Nature published the results of the latest trial involving ketamine, bolstering its potential as an antidepressant treatment. Researchers, examining the drug in mice, found that that the mood boosting effects may not be caused by ketamine itself, but instead by one of the metabolites ((2R,6R)-hydroxynorketamine) formed when the drug is broken down into smaller pieces.

Even more promising, the ketamine given to the rats did not increase side effects, even though the dose was much stronger than what would be given to humans for depression. The researchers say they want to take the metabolite into testing in humans, though that is likely years away.

The largest trial ever of ketamine in depression was done in 2013 with 73 participants. The drug lead to a decline in depression symptoms 24 hours after treatment in 64% of patients, all of whom had tried at least 3 other drugs without any results.  Antidepressant Efficacy of Ketamine in Treatment resistant depression

Despite the lack of clear-cut evidence of its benefits and unknowns about its long-term risk, many doctors are already offering ketamine as a depression treatments to patients, though this is an off-label use.

Side effects of ketamine can include confusion, lucid daydreaming, fuzzy vision, and a “high” feeling, though they tend to go away quickly, according to these doctors. Patients, who are usually given ketamine via infusion, are carefully monitored and must have pre-arranged transport home. They can’t drive or use heavy machinery for 24 hours.

Drug companies are even trying to cash in on the ketamine craze. Janssen Pharmaceutical is testing a form of ketamine it developed, called esketamine, in 5 clinical trials. It would be given via a nasal spray. Another is rapastinel, under development by Allergan. Both drugs had “breakthrough therapy designation” from the FDA, meaning they will go through the regulatory process at a much quicker rate.

NMDAR inhibition-independent antidepressant actions of ketamine metabolites

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CBD Gummies for Anxiety and Depression :
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CBD become one of the most sought-after medicines on the market today. Not only is it able to treat a wide range of ailments ranging from cancer to arthritis, CBD is known to be effective without causing any obvious side effects. It can be used safely in the long-term without causing addiction and dependence.

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There are tons of ways to use CBD, and one of the most popular is to use CBD gummies. These products provide patients with a tasty and fun way to medicate themselves. In this article, we’re going to talk about the use of CBD gummies for helping to fight off anxiety and depression.

What is CBD?

CBD, also known as cannabidiol, is one of the main cannabinoids found in the cannabis and hemp plants. CBD is known to treat a number of illnesses, both mental and physical. Some of the things that CBD is most commonly used to treat include:

  • Arthritis and other inflammatory conditions
  • Anxiety, depression, and other mental health problems
  • Cancer
  • Various diseases of the intestinal tract like IBS and Crohn’s disease
  • Various forms of pain, both chronic and acute

These are just a few of the things that CBD can be useful for treating. CBD works by affecting the body’s endocannabinoid system, a system of neurotransmitters that affects a huge number of our bodily processes. We’ll touch on that later in the neurochemistry section.

CBD is attractive to a number of people because it presents a holistic alternative to a lot of pharmaceutical medications. Many people find that their pharmaceuticals may be effective for treating a problem on the surface, but the side effects often compete with the benefits and in the long-run the illness is rarely treated.

CBD gummies, on the other hand, can help people manage the symptoms of their illnesses without actually becoming dependent on a drug or overwhelmed by side effects. This provides a unique opportunity to actually heal the root of the problem.

CBD vs THC

Many people are hesitant to use CBD because they know that it comes from the same plant as THC. THC, or tetrahydrocannabinol, is another cannabinoid. This one is largely responsible for many of the psychoactive effects that a person can experience when smoking marijuana.

Marijuana is quite a powerful drug and it’s understandable that some people would want to ensure that they’re not going to get high when using CBD. Rest assured, CBD and THC have vastly different effects, and CBD is not psychoactive at all.

This is interesting because structurally, CBD and THC are almost identical. Their molecules have the same number and same type of atoms; they are simply arranged differently. This contributes to the vast differences in experiences when using these two compounds.

CBD Effects

The interesting thing about CBD is that it will not have many effects if you are not treating an actual problem. That is to say, CBD works by helping to restore balance and function to the endocannabinoid system (ECS), as mentioned earlier. If your endocannabinoid system is in perfect health, then taking CBD won’t do much for you.

Unfortunately, the reality is that most of us have at least some imbalance in our ECS. These imbalances can come from a number of things that we’re exposed to on a daily basis: pollution, stress, unhealthy food, etc.

For these people, CBD is known for providing a number of positive benefits:

  • Reduced inflammation, improving pain and swelling for people with problems like arthritis
  • Increased relaxation and ability to fall asleep
  • Reduced anxiety and depression
  • Improved sociability
  • Improved concentration
  • Improved digestion

All of these benefits can work together to help ward off various illnesses and diseases.

Does CBD Get You High?

CBD does not get you high. As mentioned earlier, the CBD molecule is nearly identical to the THC molecule. However, because of the arrangement of these molecules, the two compounds act entirely different inside the body.

THC directly affects the body whereas CBD indirectly affects the body. This is why THC is much more apparent when ingested than CBD.

CBD Gummies

CBD Products

There are a huge number of different products containing CBD available. The variety in products allows for patients to choose from a number of ways of consuming CBD. The different methods of taking CBD will provide differences in the effects and duration of the substance.

  • CBD oil and tinctures are among the most popular CBD products. These oils and tinctures are so popular that we have dedicated a section to them below.
  • CBD capsules. Capsules are great for oral use but they can also be broken apart and taken sublingually or under-the-tongue. Capsules tend to come on slower than the other methods of using CBD but they also last for a bit longer.
  • Smokeables and vape products are useful for people who have acute problems like pain or panic attacks. These products can be inhaled and the effects felt almost immediately, though they tend to wear off much quicker.
  • Topical products. There are a number of products made with CBD that can be applied directly to the skin. These products are great because the active ingredient can be absorbed into the skin and there won’t be any effects on a person’s mental or physical site except where they apply it.

CBD Oil

CBD oil is one of the most popular forms of using CBD. This is because the oil provides you with a concentrated form of the active extract that can be consumed in a number of ways

The most effective way to use CBD oil is to take it sublingually. This involves holding the oil under your tongue for about 5 minutes so the CBD can be absorbed into the blood vessels there. This causes it to hit you faster and you’ll end up using less of it this way, thus saving money.

CBD oil is also used in the making of a number of other CBD products, like edibles.

CBD Edibles

CBD edibles are one of the most popular ways to consume CBD. People have had great success using CBD oil to make snacks and treats filled with CBD that people can eat. Ranging from CBD gummies to CBD peanut butter, edibles are a great way to medicate yourself.

One of the best things about edibles is that they are more slowly metabolized than the other forms of CBD. This means that the active effects may come on a bit slower but they will linger for much longer.

CBD and Anxiety

One of the most popular uses for CBD gummies and other forms of CBD is for helping people manage anxiety.

Many people were baffled by the implications of this, particularly because THC is well-known for causing anxiety in many people. Folks were wondering how a cannabinoid – especially one so similar to THC – could be used for fighting anxiety.

We’ll discuss the reasoning a bit more in the neurochemistry section below. For now, the simple fact of the matter is that CBD helps to manage anxiety by relaxing the mind and body, as well as balancing out the endocannabinoid system.

CBD has been shown to be useful for fighting all sorts of anxiety, ranging from generalized anxiety to panic disorder. Many have found success using a vape pen to help them manage acute panic attacks. CBD has even been shown to help fight anxiety associated with serious conditions like post-traumatic stress disorder.

CBD and Depression

CBD has proven to be a very exciting alternative for helping people manage depression.

Many traditional antidepressants are known for causing a huge number of side effects. These drugs often take a long time to work – many people have to use them for up to three weeks before these drugs work – and they often have drastic effects on a person’s physical and mental health.

CBD might not be as potent as some of these antidepressants, but it targets the problem in a much more holistic manner. Instead of blunting your emotions or inhibiting your ability to feel depressed by overloading your brain with neurotransmitters, CBD helps you overcome acute symptoms of depression so you’re actually able to identify and heal the root of the problem.

CBD gummies and other forms of CBD are a great tool for helping some people get the treatment that they need to actually eliminate their depression. After this, they can stop using CBD. This is in stark contrast to traditional antidepressants which many people find themselves using for the rest of their lives.

Neurochemistry and CBD

We have touched on the subject of CBD and neurochemistry in this article, but only briefly. In this section we will give a bit more information about the way CBD affects our brain and nervous system.

As mentioned, CBD affects the ECS. This massive system of neurotransmitters and receptors is responsible for governing many facets of our brains and bodies. It helps to regulate our immune system, manage our digestion, regulate our mental health, and generally help to ensure that we function properly.

Unfortunately, many of us have an imbalance in the ECS. CBD works by helping to restore balance to this vast system by indirectly influencing it.

This is one of the reasons that CBD has such vastly different effects than THC. THC directly binds to what are known as cannabinoid receptors. By binding to these receptors, THC can have a direct, immediate, and profound effect on this entire system.

CBD, on the other hand, works indirectly. Not only does it not bind to the receptors, but it actually makes it more difficult for substances like THC to bind to them. Instead, CBD works ‘behind the scenes’ to have a positive and regulatory effect on certain neurotransmitters like dopamine, serotonin, and our own naturally produced cannabinoids.

CBD Dosage

The dosage that one requires when they are using CBD depends on their condition and how serious it is. Dosages vary greatly between people and since CBD hasn’t been approved by federal organizations there is no standard dosage.

However, there are certainly some standards that one could expect to use.

  • People with anxiety may need anywhere from 10 to 50 mg of CBD. 10 mg doses of capsules or oils can be useful for helping to treat mild-to-moderate social anxiety and general anxiety. Higher doses can stave off a panic attack in its tracks.
  • People with pain or inflammation often require slightly higher doses. 20 mg can be effective for mild-to-moderate inflammation, but doses of anywhere from 50-100 mg are quite common.
  • People with depression often take higher doses, beginning at around 50 mg. However, people with melancholy or mild depression caused by situations or events can find some improvement using around 20 mg.

Keep in mind the way that you consume your CBD also has an impact on how much you need. Consuming CBD gummies or tinctures orally causes some of the drug to be destroyed by the liver before it’s absorbed into the bloodstream. Taking it sublingually helps to prevent this and reduces the amount required by about 40 percent.

CBD Side Effects

The vast majority of people won’t experience any side effects from CBD. Aside from the fact that higher doses might make you sleepy and unfit to drive a motor vehicle, CBD won’t cause any serious side effects unless you are allergic to cannabinoids.

That said, some people are extremely sensitive to the compound. These people may experience symptoms like dry mouth, diarrhea, and nausea. However, this may indicate that the medicine was not prepared properly or was produced in a facility with low safety and health standards.

One thing to be noted is that people using THC for recreational purposes might find the effects diminished if they use CBD. However, people who are using THC for medicinal purposes often find that the benefits are enhanced when they are using CBD in addition to THC.

Hopefully, this article has helped you to better understand CBD and the powerful benefits that it can provide for you and those that you love. Good luck healing yourself with this fantastic medicine.

What is Depression?

Depression is a mental health disorder associated with significant morbidity and mortality, being a major risk factor for suicide, substance abuse, poor outcomes of medical conditions, and impaired functionality. It is characterized by flattening of mood, loss of emotional expression, and retardation of thought and movements. Individuals who have depression usually have a depressed mood, loss of interest in activities they were usually interested in, sleep disturbance, loss of energy, and reduced ability to thick or focus.

The American Psychiatric Association’s Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) categorizes depressive disorders into major depressive disorder, persistent depressive disorder, premenstrual dysphoric disorder, disruptive mood dysregulation disorder, and depressive disorder due to a medical condition. However, all these classes of depression are characterized by the presence of a sad or irritable mood with associated difficulty in thinking, concentrating, and carrying out normal physical tasks, impairing the individual’s daily functioning.

Stats about Depression

Between 2009 and 2012, approximately 7.6% of Americans aged 12 and above were diagnosed with depression and it was more common among females and persons aged 40 and 59. In 2015, about 16.1 million adults aged 18 and over had a minimum of one depressive episode in the previous year.

Depression has been found to occur in children at an incidence rate of 0.9% in preschool-aged children, 1.9% in school-aged children, and approximately 4.7% in adolescents. In prepubertal children, depression occurs in boys and girls at an equal rate. Generally, depression in men and women has the highest rates in those aged between 25 to 44 years and the incidence of severe depression increases with age.

What are the Traditional Treatments for Depression?

There is a wide range of treatments for depression which have proven effective in improving symptoms. A combination of medications and psychotherapy is effective in reducing the symptoms of depression, and therapy with either form alone is often ineffective. Combination therapy has been found to increase quality of life and improve treatment compliance in patients with depression.

Advanced treatment techniques used for the treatment of depression include electroconvulsive therapy which uses high-energy electric stimulation, and bright-light therapy involving exposure of an individual with depression to bright light at an intensity of 10,000 lux for a period of one hour in the morning.

Therapy for Depression

Psychotherapy is often combined with medications in the treatment of depression. There are different types of therapy for depression and these can be grouped based on their efficacies. A therapy is considered “efficacious and specific” if studies in at least two settings (hospital, home therapy, rehab center etc.) have proven it more effective than medications. A therapy is considered “efficacious” if it has been proven from at least two settings that it is superior to no treatment at all, and it is “possibly efficacious” if it has been proven effective in at least one study in a single setting.

Examples of efficacious and specific therapies include cognitive behavioral therapy, problem-solving therapy, and interpersonal therapy which help the individual modify their behaviors and interpersonal relationships. An example of an efficacious therapy includes mindfulness-based cognitive therapy to prevent a recurrence or relapse, and an example of possibly efficacious therapy is continuation cognitive therapy to prevent recurrence by helping the individual develop positive thinking and behavioral patterns.

Medications for Depression

Medications used for treating depression are of different classes, each with a different mechanism of action, characteristics, and side effects. Some of these drugs include Fluoxetine (Prozac), Citalopram, Amitriptyline, Imipramine, and Nortriptyline. These drugs generally increase the concentration of stimulant substances in the brain to improve the depressive symptoms.

Home Remedies for Depression

Patients with depression could benefit from a number of home remedies which could help to improve their symptoms, in addition to antidepressants and therapy:

  • St. John’s wort – This plant, although not approved for treatment of depression by the FDA, has been linked with increased amounts of serotonin in the body correlating to improvement of depressive symptoms.
  • Omega-3 fatty acids – Omega-3 fatty acids are commonly found in fish such as salmon, sardines, and trout, and this substance has been linked to improvement in depressive symptoms.
  • SAM-e – S-adenosylmethionine (SAM-e) is artificially designed to function like chemicals in the brain which elevate mood. It is considered a supplement useful in improving symptoms of depression.
  • Folate – Folic acid which is found in a number of foods such as beans, lentils, dark leafy greens, and fortified cereals have been found to improve the effectiveness of medications used in treating the disorder.

What is CBD?

Cannabidiol (CBD) is a naturally occurring chemical compound found in the hemp plant. It is one of the numerous unique compounds called cannabinoids which naturally occur in hemp. Generally, cannabinoids can be produced in the body (these are known as endocannabinoids) or found in the hemp plant as phytocannabinoids. CBD is industrially extracted from the cannabis plant and separated from the other cannabinoids, representing about 40% of cannabis extracts.

CBD is a phytocannabinoid which helps to stimulate the regulation of the central nervous system. CBD, therefore, helps supplement the effects of endocannabinoids in regulating appetite, mood, functions of the immune system, sensation, and keeping our bodies working normally. CBD oil is made from hemp plants and can be purchased legally in the United States. CBD is available in different forms such as tinctures, concentrates, capsules, sprays, tapes, and topicals.

CBD vs. THC

Most times, people interchange CBD for tetrahydrocannabinol (THC), another cannabinoid found in the hemp plant. Both of them represent the commonest compounds found in the plant. However, they have numerous differences.

THC, unlike CBD, is intoxicating causing a high and euphoria. It is responsible for the “high” felt by marijuana users. CBD, on the other hand, is not a psychoactive substance as it does not act via the same biological pathways in the body as THC.

CBD Oil Effects

Although, CBD oil has not been approved by the FDA for the treatment of any condition, there have been several studies demonstrating some of its health benefits:

  • CBD has been shown to have anti-oxidant properties which means that it is capable of mopping up toxic substances obtained from food or generated in the body. These substances are often at the center of inflammatory conditions such as myocardial infarction, inflammatory bowel disease, and stroke.
  • Oxidative stress caused by the release of these toxic substances causes age-related diseases such as Alzheimer’s disease and Parkinson’s disease and CBD has been found to protect against these degenerative diseases of the brain and reduce their clinical progression in patients suffering from them. CBD may also help in the clinical improvement of some autoimmune disease such as lupus and rheumatoid arthritis.
  • Clinical trials have shown that CBD oils are effective in the treatment of epilepsy and other seizure disorders.
  • Studies have shown that CBD may have therapeutic benefits for brain disorders such as psychosis, depression, and multiple sclerosis.
  • Other benefits of CBD are currently being investigated, including its effects on anxiety and depression, as well as on social anxiety disorder and post-traumatic stress disorder.

Does CBD Get You High?

CBD is a non-psychoactive form of cannabinoid which has been found not to interfere with the cognitive functions of the brain. It does not get you “high,” in contrast to THC, which alters the cognitive functions of the brain.

Is CBD Addictive?

According to a recent report by the World Health Organization (WHO), CBD is not addictive and it has no potential for abuse or dependence. This is mainly because CBD does not contain any addictive substances, in contrast to THC and some cannabinoids which contain such and are, therefore, capable of being addictive.

Is CBD Safe?

There have been extensive reviews on the toxic potentials of CBD and reports have revealed that CBD has a relatively low toxicity. It has been found to be safe with little potential for adverse effects. CBD was found to have no effect on fetal development and other bodily functions. Generally, CBD does not produce the adverse effects seen with THC and other psychoactive cannabinoids. However, reports demonstrate that some reactions may occur as a result of its interactions with other drugs co-administered with it.

How Could CBD Help with Depression?

CBD has been found to be effective in the treatment of depression. While CBD does not cure the condition, it has been linked to improvement of the symptoms.

The cannabinoids produced in our bodies (endocannabinoids) help to regulate several functions of the body such as mood, pain sensation, sleep, and appetite. These substances exert their actions by binding to specific points of brain cells called the receptors through which they potentiate the actions of a substance called serotonin which acts to improve mood and reduce stress levels. Serotonin also acts by binding to its receptors in brain cells. When these chemical substances bind to their respective receptors, they trigger a series of events within each brain cell stimulating processes that improve mood and stress control.

CBD has been found to help improve depressive symptoms by modulating the actions of the endocannabinoids and also potentiating the effects of serotonin by enhancing the activity of the receptors unto which serotonin binds.

CBD oil helps to significantly improve depressive symptoms and the individual’s quality of life.

CBD Oil Dosage

CBD oil is available in several forms including tinctures, capsules, concentrates, and topical forms. However, it is most commonly administered orally. It is important to note that CBD is most effective when used regularly in maintenance doses, though it may be used for treating acute flare-ups.

In the management of depression, CBD oil may be taken in the tincture and capsule forms. Individuals with depression can begin with a dose of 5 to 10mg daily until the desired results are achieved. Gel capsules of CBD are available as 25mg per pill and it is safe to begin at this dosage as CBD has a good safety profile. The effects of CBD lasts several hours after a dose is ingested and most persons report feeling better for up to 24 hours. However, you will only begin to notice these improvements after 90 minutes of ingestion of CBD oil.

For managing acute flare-ups, it is best to vaporize CBD isolate for fast relief of symptoms. However, the maintenance dose should not be discontinued. Although you may also use the ingestible forms of CBD in treating acute flare-ups, these, generally, have a relatively longer onset of action.

Generally, it is recommended that you consult with your physician before starting CBD oils to prevent drug interactions and exacerbations of any medical conditions you may have. Do not, also, discontinue or start any drug while using CBD without consulting your physician.

For information on where to obtain CBD Oil, go here.

CBD Oil Side Effects

CBD oil is generally safe to use with minimal risk of adverse effects. Side effects may be seen when high doses are taken. Some studies have revealed that if taken at high doses, it may cause a weakening of your immune system. However, the main concern with the use of CBD is the risk of drug interactions, therefore, it is recommended that you consult your physician before using CBD oil.

Bottom Line: Can CBD Help You?

CBD is one of the naturally occurring chemical substances found in the cannabis plant and though the stigma associated with the psychoactive counterpart, THC, has rubbed off on it, it has been shown to have immense health benefits in treating conditions such as anxiety, depression, mood disorders, and inflammatory diseases. CBD oil helps to significantly improve depressive symptoms and the individual’s quality of life. However, it should be noted that CBD does not provide a cure for the disorder, but leads to a better quality of life for the patient.

Resources

https://emedicine.medscape.com/article/286759-overview#a4

https://www.webmd.com/depression/features/natural-treatments#1

https://www.healthline.com/health/depression/herbs-supplements

https://ministryofhemp.com/wp-content/uploads/2016/10/The-Complete-CBD-Resource.pdf

https://www.royalqueenseeds.com/blog-new-who-report-shows-cbd-is-not-addictive-nor-dangerous-n771

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3648779/

https://keytocannabis.com/blogs/cannabis/cbd-for-depression

https://www.ncbi.nlm.nih.gov/pubmed/24923339

https://www.ncbi.nlm.nih.gov/pubmed/22729452

https://www.ncbi.nlm.nih.gov/pubmed/20002102

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Learn How Ketamine Can Treat Post Traumatic Stress Disorder ICD 10

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Learn How Ketamine Can Treat Post Traumatic Stress Disorder

For decades, ketamine has been used as a medicinal intervention for treating depression, anxiety, mood disorders, and post-traumatic stress disorder (PTSD). While most ketamine advocates recognize its therapeutic potential for treating depression, the many benefits available to those suffering from PTSD are less understood.

Do you or a loved one suffer from post-traumatic stress disorder? If so, ketamine infusion therapy may be able to help alleviate your symptoms and provide the relief you need. However, public knowledge about medicinal ketamine is lacking. In this article, we go over everything there is to know about ketamine for treating PTSD.

PTSD 101: What You Need to Know

Post-traumatic stress disorder has a medical diagnostic code of ICD-10, which is the code used for reimbursing treatment through your insurance provider. PTSD, unlike other mental illnesses, is characterized by its triggering from a single or series of traumatic events. This explains why PTSD is common among military veterans and first responders.

According to a summary article from Mayo Clinic, PTSD is a mental health condition triggered by a terrifying experience. The sufferer subsequently experiences flashbacks, night terrors, and anxiety attacks that they cannot control as a result of the event. It takes a significant amount of time, therapy, and self-care to overcome the trauma of PTSD.

There is no known cure for PTSD. However, many experimental medicinal interventions are breaking ground when it comes to finding a cure. For example, the psychoactive drugs MDMA and ketamine have both been studied for their potential to alleviate the negative effects of PTSD.

Ketamine Infusion Therapy

Since the early 2000s, ketamine has gained popularity among medical providers for its application in infusion therapies. In recent years, clinics all around the world have embraced the healing power of ketamine by offering ketamine infusion therapy. This unique therapy involves one or more intravenous injections of ketamine under the supervision of an anesthesiologist.

What Is Ketamine?

Although ketamine has garnered a reputation as a party drug, its primary value is in its ability to provide fast-acting and potent relief for those with chronic pain issues. Ketamine was first synthesized in the 1960s and was later adopted as an anesthetic in veterinary medicine by the end of the decade. However, use in humans was initially sparse.

Ketamine is both an analgesic and anesthetic drug, which means its primary quality is to reduce or prevent pain. This makes ketamine highly effective for treating major depressive disorder, chronic back pain, and PTSD.

Ketamine and PTSD

Ketamine-infusion-clinics-across-mi

Ketamine infusion clinics across the United States are now offering specialty treatments for those suffering from PTSD. For example, the renowned Ketamine Clinics of Los Angeles has treated hundreds of PTSD patients over the years. Led by Dr. Steven Mandel, M.D., the team at Ketamine Clinics of LA has a proven track record of helping relieve the pain of PTSD.

An increasing amount of scientific research has proven that ketamine is effective in treating PTSD. Most notably, a breakthrough 2014 study in JAMA Psychiatry discovered that a single intravenous subanesthetic dose of ketamine resulted in “significant and rapid reduction in PTSD symptom severity.”

Over the past few years, many articles and news reports have heralded ketamine as a potential wonder drug for treating PTSD. A recent article published by Medscape discussed how a team of researchers at the Icahn School of Medicine at Mount Sinai in New York City used ketamine to fight depressive symptoms in patients with PTSD and severe depression.

Is Ketamine Safe for PTSD?

There is no doubt that ketamine is a novel treatment for many PTSD sufferers. Since it is a relatively new medicinal intervention, there is some skepticism within the medical community regarding whether it is safe for human use. However, many of these doubts have been quelled over the years thanks to numerous studies and experiences that have proven its safety.

The most compelling evidence suggesting that ketamine infusion is safe in humans comes from a 2014 clinical study. This study managed to safely administer low doses of ketamine to treat neuropathic pain states in adults. Over the two-week monitoring period, the patients exhibited numerous benefits while experiencing only marginal or negligible side effects.

It should be noted that ketamine is not safe if taken recreationally. Since its inception, ketamine has gained a reputation as a party drug for its ability to induce dissociative states and euphoria. However, ketamine is not safe to use unless administered by a licensed physician. It is possible to overdose on ketamine, and the side effects of using high doses of ketamine can be fatal.

Ketamine: A PTSD Prevention Tool?

Interestingly, ketamine has found success as a tool for preventing the onset of PTSD. In one case, a research team gave a family of mice a low dose of ketamine before exposing them to electric shocks. Usually, mice exhibit symptoms of PTSD after being exposed to such a severe stressor. However, the mice that were given ketamine did not exhibit these symptoms at all.

Typically, traumatized mice freeze up when they are placed back in the cage in which they were shocked. In this case, the mice who were sedated with ketamine did not freeze when placed in the cage or froze for a significantly reduced duration. This led the research team to believe that ketamine may have value in both preventing and treating PTSD in humans.

Is Ketamine Right for You?

Ketamine may be an appropriate treatment option for you if you have treatment-resistant PTSD. In other words, you must first be diagnosed with PTSD and have sought the traditional frontline treatments for the condition before considering ketamine infusion therapy. We recommend speaking with your doctor about your PTSD symptoms and the appropriate therapies available to you. Usually, SSRIs or benzodiazepine pharmaceutical drugs, in conjunction with cognitive behavioral therapy (CBT) is the first method of treatment. However, if you do not respond well to this treatment option you should consider seeking ketamine therapy.

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The Effects of Intranasal Ketamine on Treatment-Resistant Depression

As I have previously reported, off-label use of ketamine for treatment-resistant depression has resulted in numerous anecdotal reports regarding its unique mechanism of action and overwhelming success in symptom reduction among treatment-resistant and suicidal patients.

This is an important finding because approximately one-third of patients with major depressive disorder (MDD) do not respond to currently available antidepressants. As a result, The American Psychiatric Association (APA, 2016) had issued guidelines for psychiatrists who wish to use ketamine for this purpose. At the time, a slow intravenous infusion was the primary delivery system used to attain the reported results. There are of course numerous challenges and costs associated with this delivery system, including the use of a clinical facility with available advanced life support systems in place.

What Is Ketamine?

Ketamine was developed and FDA approved more than 50 years ago as a fast-acting anesthetic with an impressive safety profile. It is still used today in anesthesiology on both pediatric and adult patients and animals. Ketamine in higher doses also has unique dissociative properties, which explains its popularity as a club drug known as “Special K” in the U.S. It is currently a highly abused club drug in southern Asia today.

Intranasal Ketamine Clinical Trial

In this well-designed original research conducted by Daly and colleagues, a phase 2, double-blind, doubly randomized, placebo-controlled study was employed to assess the efficacy, safety and dose-response of intranasal esketamine hydrochloride (ketamine) in patients with treatment-resistant depression (TRD). The primary positive endpoint was a statistically significant change from baseline to day eight during each study period, measured by the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS).

This study consisted of four phases:

  1. Screening
  2. Double-blind treatment (days 1-15), composed of two 1-week periods
  3. Optional open-label treatment (days 15-74)
  4. Post-treatment follow-up at 8 weeks

The results are impressive. Change in MADRS total score in all three esketamine groups was superior to placebo (esketamine 28 mg: −4.2 (2.09), P = .02; 56 mg: −6.3 (2.07), P = .001; 84 mg: −9.0 (2.13), P < .001), with a significant ascending dose-response relationship (P < .001). Even more impressive is the continuous reduction of depressive symptoms despite reduced dosing frequency during the open-label phase.

Why Does This Matter?

First, the mortality rate for untreated and undertreated depression is between 15 and 20%. Moreover, depression and suicidality are increasing in the U.S., most notably among children and adolescents. Ketamine is thought to inhibit the N-Methyl-D-Aspartame (NMDA) system, which is unrelated to our 50-year-old catecholamine hypothesis, suggesting that the inhibition of NDMA is a viable, and perhaps primary, target for future intervention. In addition, there is growing anecdotal data suggesting that ketamine may also be a viable treatment for pain and perhaps even addictive disease.

Second, the results of this important study show that esketamine has a significant effect on symptom reduction among patients with TRD (Montgomery- Asberg Depression Rating Scale) after only one week of twice-weekly administration, which is substantially faster than the SSRIs or SSNRIs. It is also of interest that esketamine is well tolerated with few adverse effects, evidenced by the fact that a mere 5% of participants discontinued treatment during the double-blind phase. In addition, the use of an intranasal delivery system allows lower dosage compared to oral administration by avoiding first-pass hepatic metabolism.

Third, because of its low molecular weight (238 Daltons), esketamine is a good candidate for intranasal delivery because lower molecular weight improves nasal mucosa absorption. This route will get the dose to the brain rapidly, and for reasons that remain unclear, the therapeutic effect remains when using a twice-per-week dosing system.

All this is to say that compared to currently available oral antidepressant medications, which have a poor adherence rate, esketamine should vastly improve treatment adherence. Combined with few reported adverse effects, more people will get well. This is good day to be a neuroscientist.

Reference:
Ella J. Daly, MD; Jaskaran B. Singh, MD; Maggie Fedgchin, PharmD; Kimberly Cooper, MS; Pilar Lim, PhD; Richard C. Shelton, MD; Michael E. Thase, MD; Andrew Winokur, MD, PhD; Luc Van Nueten, MD; Husseini Manji, MD, FRCPC; Wayne C. Drevets, MD Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression. A Randomized Clinical Trial. JAMA Psychiatry. doi:10.1001/jamapsychiatry.2017.3739. Published online December 27, 2017.

Additional resource for Gambling disorders. Financial costs for loss from this disorder as for any addiction add up quickly. Here is a link to a resource:

Financial strategies for loved ones of problem gamblers

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Can We stop Suicides?

The link above attached to the New York Times article opinion section that discusses Ketamine and its transforming ability for depression and related mood  disorders. Below is the excerpt:

In May of 2017, Louise decided that her life was just too difficult, so she’d end it. In the previous four years, three siblings and a half-sibling had died, two from disease, one from fire and one from choking. Close friends had moved away. She felt painfully, unbearably alone. It would be the fourth time Louise (I’m using her middle name to protect her privacy), then 68, would attempt suicide, and she was determined to get it right.

She wrote a letter with instructions on where to find important documents and who should inherit what. She packed up her jewelry and artwork, addressing each box to particular friends and family members. Then she checked into a motel — homes where people have committed suicide lose value and she didn’t want hers to sell below market — put a plastic sheet on the bed, lay down and swallowed what she figured was an overdose of prescription pills with champagne.

A few days later, she woke up in a psychiatric ward in Albuquerque. The motel maid had found her. “I was very upset I had failed,” she told me recently. So she tried to cut her wrists with a bracelet she was wearing — unsuccessfully.

The suicide rate has been rising in the United States since the beginning of the century, and is now the 10th leading cause of death, according to the Centers for Disease Control and Prevention. It’s often called a public health crisis. And yet no new classes of drugs have been developed to treat depression (and by extension suicidality) in about 30 years, since the advent of selective serotonin reuptake inhibitors like Prozac.

The trend most likely has social causes — lack of access to mental health care, economic stress, loneliness and despair, the opioid epidemic, and the unique difficulties facing small-town America. These are serious problems that need long-term solutions. But in the meantime, the field of psychiatry desperately needs new treatment options for patients who show up with a stomach full of pills.

Now, scientists think that they may have found one — an old anesthetic called ketamine that, at low doses, can halt suicidal thoughts almost immediately

Depression ran in Louise’s family. It had afflicted all her siblings, both of her parents and her grandmother. Prozac had helped Louise for a time, but stopped working for her in the late 2000s, as it sometimes does. No other drug seemed able to lift her dark moods.

After her suicide attempt, Louise’s psychiatrist suggested she try ketamine. She agreed, and received an infusion intravenously. Within hours, her sense of well-being improved. The hospital discharged her. Back home, she discovered that going to the market was no longer a “herculean task.” Getting her car washed wasn’t an insurmountable chore. “Life was better,” she said. “Life was doable.”

Using ketamine to treat depression and suicidality is somewhat controversial. Numerous small studies suggest that it holds great promise, but it’s only now being tested in placebo-controlled trials with hundreds of patients. It is also popular as a club drug in some circles. Like morphine, it may operate on the opioid system, and it can induce feelings of euphoria. Occasionally ketamine abusers develop severe symptoms, including brain damage, persistent hallucinations and a painful inflammation of the bladder called cystitis.

Nonetheless, if proven safe and effective in small doses, ketamine stands to transform how doctors deal with suicidal patients and depression generally.

The drug seems to address a longstanding problem in emergency psychiatry. Sedation and physical restraint aside, doctors have few ways to quickly stop suicidal ideation, or thoughts of killing oneself. The current crop of anti-depressants can take weeks and sometimes months to work, if they work at all. They may also, paradoxically, increase suicidality in some patients. Talk therapy takes time to help as well (assuming it does). Here’s a sobering fact: Some studies indicate that suicide risk peaks soon after patients have been discharged from a medical facility.

Antidepressants and Suicide Risk A Comprehensive Overview

Antidepressants and Suicide Risk A Comprehensive Overview

Suicide risk peaks in first week of psychiatric hospitalisation and post discharge  <, See commentary excerpt at bottom of this page

 

Researchers at Yale discovered ketamine’s potential as an antidepressant in the late 1990s and scientists at the National Institute of Mental Health confirmed it the mid 2000s. Numerous studies followed suggesting that the drug helps precisely with that subset of depressive patients — about a third — for whom nothing else works. It doesn’t work for everyone in this group, but when it does, it works within hours, not weeks.

A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression<<<Carlos Zarate

Suicidality doesn’t perfectly overlap with depression. Many people attempt suicide not because they’re clinically depressed, but rather impulsively, because they’ve been fired or they’ve broken up with girl- and boyfriends, or sometimes because they’re just really drunk. I’ve heard people who show up in the hospital in this state — despondent, angry and uninhibited more than depressed — described as “drunkicidal.”

Many are fine once they sober up. For those who aren’t, ketamine may help independent of its effect on depression. And because ketamine is already approved by the Food and Drug Administration, doctors can prescribe it off-label. Meaning that not only does a drug exist right now that could help with depression and suicidality, it’s theoretically available to patients.

I kept thinking about this during the recent spate of high-profile suicides: the chef Anthony Bourdain, the designer Kate Spade, the actress Margot Kidder. Could ketamine have saved any of them? Did they know about it? Did their psychiatrists?

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Seasonal Affective Disorder and Ketamine Infusions as a rapid treatment

 

Do you find yourself getting depressed and sad in the fall and wintertime despite your best efforts? Seasonal affective disorder is common and can disrupt your lifestyle and happiness. Consider Ketamine infusions as an option for immediate relief with follow through intranasal ketamine. We can provide these solutions for people suffering from this disorder. A series of 2- 6 infusions can manage the majority of patients with rapid recover, almost within a few days. 

Seasonal Affective Disorder, or SAD, is a type of recurrent major depressive disorder in which episodes of depression occur during the same season each year. This condition is sometimes called the “winter blues.”

Definition

Seasonal affective disorder (also called SAD) is form of depression in which people experience depressive episodes during specific times of the year. The most common seasonal pattern is for depressive episodes to being in the fall or winter and diminish in the spring. A less common type of SAD, known as summer depression, usually begins in the late spring or early summer. SAD may be related to changes in the amount of daylight a person receives.

SAD is not considered as a separate disorder, but rather is a type of depression that has a recurring seasonal pattern. To be diagnosed with SAD, an individual must meet criteria for major depression coinciding with specific seasons for at least two years. The individual must experience seasonal depressions much more frequently than any non-seasonal depressions.

Seasonal affective disorder is estimated to affect 10 million Americans. Another 10 percent to 20 percent may have mild SAD. SAD is four times more common in women than in men. The age of onset is estimated to be between the age of 18 and 30. Some people experience symptoms severe enough to affect quality of life, and 6 percent require hospitalization. Many people with SAD report at least one close relative with a psychiatric disorder, most frequently a severe depressive disorder (55 percent) or alcohol abuse (34 percent).

Symptoms

Not everyone with SAD has the same symptoms, but symptoms commonly associated with the “winter blues” include the following:

  • Feelings of hopelessness and sadness
  • Thoughts of suicide
  • Hypersomnia or a tendency to oversleep
  • A change in appetite, especially a craving for sweet or starchy foods
  • Weight gain
  • A heavy feeling in the arms or legs
  • A drop in energy level
  • Decreased physical activity
  • Fatigue
  • Difficulty concentrating
  • Irritability
  • Increased sensitivity to social rejection
  • Avoidance of social situations

Symptoms of summer SAD are:

  • Poor appetite
  • Weight loss
  • Insomnia
  • Agitation and anxiety

Either type of SAD may also include some of the symptoms that are present in major depression, such as feelings of guilt, a loss of interest or pleasure in activities previously enjoyed, ongoing feelings of hopelessness or helplessness, or physical problems such as headaches and stomach aches.

Symptoms of SAD tend to reoccur at about the same time every year. To be diagnosed with SAD, the changes in mood should not be a direct result of obvious seasonal stressors (like being regularly unemployed during the winter). Usually, this form of depression is mild or moderate. However, some people experience severe symptoms that leave them unable to function in their daily lives.

Seasonal affective disorder can be misdiagnosed as hypothyroidyism, hypoglycemia, or a viral infection such as mononucleosis.

Causes

The cause for SAD is unknown. One theory is that it is related to the amount of melatonin in the body, a hormone secreted by the pineal gland. Darkness increases the body’s production of melatonin, which regulates sleep. As the winter days get shorter and darker, melatonin production in the body increases and people tend to feel sleepier and more lethargic.

Another theory is that people with SAD may have trouble regulating their levels of serotonin, which is a major neurotransmitter involved in mood. Finally, research has suggested that people with SAD also may produce less Vitamin D, which is believed to play a role in serotonin activity. Vitamin D insufficiency may be associated with clinically significant depression symptoms.

There are several known risk factors that increase an individuals chance of developing SAD. For example, SAD is more frequent in people who live far north or south of the equator. Additionally, people with a family history of other types of depression are more likely to develop SAD than people who do not have this family history.

Treatments

Treatment approaches to alleviate the symptoms of SAD typically include combinations of antidepressant medication, light therapy, Vitamin D, and counseling.

Because winter depression may be caused by a reaction to a lack of sunlight, broad-band light therapy is frequently used as a treatment option. This therapy requires a light box or a light visor worn on the head like a cap. The individual either sits in front of the light box or wears light visor for a certain length of time each day. Generally, light therapy takes between 30 and 60 minutes each day throughout the fall and winter. The amount of time required varies with each individual. When light therapy is sufficient to reduce symptoms and to increase energy level, the individual continues to use it until enough daylight is available, typically in the springtime. Stopping light therapy too soon can result in a return of symptoms.

When used properly, light therapy seems to have few side effects. The side effects that do arise include eyestrain, headache, fatigue, irritability, and inability to sleep (when light therapy is used too late in the day). People with manic depressive disorders, skin that is sensitive to light, or medical conditions that make their eyes vulnerable to light damage may not be good candidates for light therapy.

When light therapy does not improve symptoms within a few days, then medication and behavioral therapies such as CBT should be introduced. In some cases, light therapy can be used in combination with one or all of these therapies.

Self-Care

  • Monitor your mood and energy level
  • Take advantage of available sunlight
  • Plan pleasurable activities for the winter season
  • Plan physical activities
  • Approach the winter season with a positive attitude
  • When symptoms develop seek help sooner rather than later
  • Light therapy and lamps for SAD
  • IV Vitamin Therapy for rapid recovery including Vitamin D injections

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Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study

 

Oral Ketamine
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BackgroundKetamine has been demonstrated to improve depressive symptoms.

AimsEvaluation of efficacy, safety and feasibility of repeated oral ketamine for out-patients with treatment-resistant depression (TRD).

MethodIn a randomised, double-blind, placebo-controlled, proof-of-concept trial, 41 participants received either 1 mg/kg oral ketamine or placebo thrice weekly for 21 days (ClinicalTrials.gov Identifier: NCT02037503). Evaluation was performed at baseline, 40 and 240 min post administration and on days 3, 7, 14 and 21. The main outcome measure was change in Montgomery–Åsberg Depression Rating Scale (MADRS).

ResultsTwenty-two participants were randomised to the ketamine group, and 19 to the control, with 82.5% (n = 33) completing the study. In the ketamine group, a decrease in depressive symptoms was evident at all time points, whereas in the control group a decrease was evident only 40 min post administration. The reduction in MADRS score on day 21 was 12.75 in the ketamine group versus 2.49 points with placebo (P < 0.001). Six participants in the ketamine group (27.3%) achieved remission compared with none of the controls (P < 0.05). The number needed to treat for remission was 3.7. Side-effects were mild and transient.

ConclusionsRepeated oral ketamine produced rapid and persistent amelioration of depressive symptoms in out-patients with TRD, and was well tolerated. These results suggest that add-on oral ketamine may hold significant promise in the care of patients suffering from TRD in the community.

 

Repeated oral ketamine produced rapid and persistent improvement of depressive symptoms in a small sample of outpatients with treatment-resistant depression who continued their usual treatment, according to a proof-of-concept study published in The British Journal of Psychiatry.

The results also showed that repeated oral ketamine was well tolerated among these participants in a community setting.

“Intravenous ketamine … has been demonstrated to act as a novel antidepressant, with an extended effect following repeated infusions while maintaining a good safety profile,” Yoav Domany, MD, from Tel Aviv Sourasky Medical Center and Sackler School of Medicine, and postdoctoral research fellow, department of psychiatry and behavioral neuroscience, University of Cincinnati, and colleagues wrote. “However, intravenous administration presents major obstacles to clinical applicability, especially in community setting.”

Though previous study has examined IV and intranasal ketamine for treatment-resistant depression, research on oral ketamine is lacking. Therefore, the investigators conducted a randomized, placebo-controlled, proof-of-concept trial to determine the efficacy, safety and feasibility of add-on repeated oral ketamine for outpatients with treatment-resistant depression.

The researchers randomly allocated 41 participants to receive either 1 mg/kg oral ketamine or placebo three times a week for 21 days. All participants were instructed to continue taking their usual prescribed care. Patients were assessed at baseline, 40 minutes and 240 minutes after administration and on days 3, 7, 14 and 21 to measure change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores.

Of 22 participants who received treatment with ketamine and 19 who received placebo (control group), 33 patients completed the study. Among those receiving ketamine, Domany and colleagues observed a reduction in depressive symptoms between baseline and all other time points (P < .005), including day 21. In the control group, there was also a decrease in symptoms, but only at 40 minutes after initial administration (P < .05).

At the endpoint (day 21), the reduction in MADRS score was 12.75 among those receiving ketamine compared with 2.49 points among those receiving placebo (P < .001). The researchers reported that 27.3% of the ketamine group (n = 6) achieved remission as opposed to none in the control group (P < .05) at day 21.

Adverse effects were mild and transient, according to the safety analysis. Common adverse effects included increased systolic blood pressure, euphoria, dizziness and drowsiness after initial administration, all of which resolved within 1 hour. Follow-up safety evaluation at day 28 showed a maintained effect on MADRS scores in the ketamine group.

“Our results, although promising, cannot yet be applied to clinical practice without larger, randomized studies,” Domany and colleagues wrote. “Such studies are needed to address questions such as optimal dosing regimens, patient selection and treatment duration to properly assess the safety of long-term ketamine usage, the risk of misuse and the restricted means appropriate for at-home prescription.”

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Ketamine infusion well-tolerated in small sample with mood disorders

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Researchers observed no long-term adverse effects in a small sample of patients with severe and treatment-resistant mood disorders who received ketamine infusions as clinical treatment.

Although the response and remission rates after a four-infusion protocol were lower than those reported in most clinical trials, the small size and racial homogeneity of the study population limit the generalizability of these findings, according to data published in Journal of Clinical Psychiatry.

“Ketamine is being used as an off-label treatment for depression by an increasing number of providers, yet there is very little long-term data on patients who have received ketamine for more than just a few weeks,” Samuel T. Wilkinson, MD, from the department of psychiatry, Yale School of Medicine and Yale Psychiatric Hospital, told Healio Psychiatry.

“Controversy remains about whether ketamine should be used outside of research protocols due to concerns regarding potential negative clinical outcomes for repeated use, including impaired cognition, delusions and interstitial cystitis,” Wilkinson and colleagues wrote in their article.

Ketamine treatments were given in an electroconvulsive therapy suite. In late 2014, Yale began providing ketamine as an off-label therapy on a case-by-case basis for patients who could not participate in research protocols. In the current article, the authors assessed the participants’ experience over 29 months of providing ketamine as a clinical treatment for severe and treatment-resistant mood disorders.

At first, patients received a single- or double-infusion protocol (0.5 mg/kg over 40 minutes IV); but in early 2015, the researchers transitioned to a four-dose protocol over 2 weeks based on emerging evidence supporting the safety of a multiple-infusion protocol. They tracked symptom severity and set cognitive assessments at baseline and after every 6 to 12 treatments.

From October 2014 through February 2017, 54 patients received ketamine, with 518 total infusions performed. Ketamine infusions given at 0.5 mg/kg over 40 minutes were well-tolerated. Two patients discontinued treatment prematurely: one for intolerable dissociative effects and one for transient hypertension.

In the subset of 44 patients with mood disorders who began the four-infusion protocol, 45.5% responded and 27.3% remitted by the fourth infusion, which were lower rates than those reported in most previous clinical trials, according to the authors. Patients showed a significant reduction in symptoms over time. The overall mean score, as measured by the Quick Inventory of Depressive Symptomatology (Self-Report), dropped by 37.9% and the overall mean depression score dropped by 37.8%.

“While our paper has a number of limitations, one of its strengths is the long-term follow-up of a small cohort of patients who have received ketamine for depression, some for over a year,” Wilkinson told Healio Psychiatry. “Though we were not able to follow patients with the same level of rigor as a sponsored clinical trial, we observed no obvious adverse long-term effects on cognition, development of psychosis, or new-onset cases of ketamine abuse.”

In a subsample of 14 patients who received long-term ketamine infusions ranging from 12 to 45 total treatments over a course of 14 to 126 weeks, there was no evidence of cognitive decline, increased inclination for delusions or emerging symptoms consistent with cystitis.

“There remains an urgent need for more powerful and comprehensive long-term safety data on ketamine from much larger samples,” Wilkinson and colleagues wrote.

“Given that racemic ketamine hydrochloride no longer has patent protections, it is unlikely that large and long-term clinical trials will be conducted to provide such long-term safety data,” they continued. “The formation of a registry combining data from community and academic sites is therefore the most realistic way of capturing long-term data on the effectiveness and safety of ketamine as a treatment for mood disorders.” 

 

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Ketamine Treatment Center | 703-844-0184 | Alexandria, Va 22306 | Call for an appointment | Loudon County, Va 20148 20147 20152 20159 20158 20160 20165 20164 20166 20175 20177 20176 20180 20178 20105 20184 20118 20197 20117 20129 20132 20131 20135 20134 20141 20142 | Ketamine IV for depression, PTSD , OCD | Ketamine is emerging as a popular treatment for depression. New research suggests the drug acts like an opioid 

 

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Ketamine is emerging as a popular treatment for depression. New research suggests the drug acts like an opioid

 

Ketamine is emerging as a popular treatment for depression. New research suggests the drug acts like an opioid

  • Ketamine is emerging as a way to treat depression, but it appears to act like an opioid, Stanford researchers found.
  • Clinics are cropping up around the country where people receive ketamine infusions.
  • A handful of pharmaceutical companies, including Johnson & Johnson and Allergan, are using ketamine as inspiration for new prescription drugs to treat depression.

This is a vial of the animal tranquilizing drug ketamine hydrochloride, better known in the drug culture as "Special K."
703-844-0184 | Ketamine Treatment Center | Fairfax, Va | 20148 20147 20152 20159 20158 20160 20165 20164 20166 20175 20177 20176 20180 20178 20105 20184 20118 20197 20117 20129 20132 20131 20135 20134 20141 20142

This is a vial of the animal tranquilizing drug ketamine hydrochloride, better known in the drug culture as “Special K.”

Ketamine is emerging as a way to treat depression, but it appears to act like an opioid — and it may carry similar risks, Stanford researchers found.

Clinics are cropping up around the country where people receive ketamine infusions. A handful of pharmaceutical companies are using ketamine as inspiration for new prescription drugs to treat depression. Yet the new research questions whether scientists know enough about chronic ketamine use to introduce it broadly.

The drug blocks NMDA receptors, which scientists think may treat depressive symptoms. Researchers wanted to test whether it was possible to elicit this reaction without activating the brain’s opioid receptors.

To block an opioid response, they gave participants naltrexone then infused them with ketamine. To compare that response with the normal response, they also gave participants a placebo before giving them the treatment.

Naltrexone so successfully blocked the anti-depressant effects of ketamine that researchers cancelled the study after the first interval because they felt it wasn’t ethical to continue it, said Dr. Nolan Williams, one of the study’s authors and a clinical assistant professor of psychiatry and behavioral sciences at Stanford University.

When patients took naltrexone, the opioid blocker, their symptoms did not improve, suggesting ketamine must first activate opioid receptors in order to treat depression, according to the study, published Wednesday in the American Journal of Psychiatry.

That’s not to say ketamine cannot be used occasionally, but it does raise questions about using it repeatedly over time, said Dr. Alan F. Schatzberg, co-author of the study and Stanford’s Kenneth T. Norris, Jr., professor of psychiatry and behavioral sciences. He likens it to opioid painkillers being an appropriate pain treatment when used once in the emergency room but posing problems, such as the risk of dependence, when used chronically.

“More studies need to be done to fully understand ketamine before it’s widely rolled out for long-term chronic use,” Schatzberg said.

Researchers planned on studying 30 adults but stopped enrolling patients once they decided combining ketamine and naltrexone was not only ineffective but also “noxious” for many participants. They tested a total of 12 people with both naltrexone and the placebo.

Of those 12, seven who received naltrexone experienced nausea after the ketamine infusion, compared to three in the placebo group. Two participants in each group also experienced vomiting.

Participants who received the placebo and ketamine treatment reported reduced depression symptoms. But those same participants did not see a decrease in depression symptoms after receiving ketamine and opioid-blocker naltrexone.

“We essentially blocked the mechanism for producing the anti-depressant effect, which were opioids,” said Williams.

The findings may have implications for clinics offering ketamine infusions and drug manufacturers trying to commercialize ketamine-like drugs.

Ketamine is meant to be used as an anesthetic. Since ketamine is currently not indicated to treat depression, insurance typically doesn’t cover the cost of infusions, so people tend to pay out of their own pocket. One session can run more than $500.

Meanwhile, drug giant Johnson & Johnson plans to seek approval from the Food and Drug Administration for its nasal spray esketamine this year after reporting positive results from a Phase 3 trial. Allergan plans to file its drug Rapastinel, which targets the NMDA receptors like ketamine, within the next two years. VistaGen Therapeutics is working on a similar drug.

In a statement, J&J said while the study reviewed ketamine and not esketamine, the findings “are difficult to interpret because of the study’s design.”

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