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Ketamine could be first of new generation of rapid acting antidepressants, say experts

Ketamine is the first truly new pharmacological approach to treating depression in the past 50 years and could herald a new generation of rapid acting antidepressants, researchers have predicted.

“We haven’t had anything really new for about 50 or 60 years,” said Allan Young, professor of mood disorders at the Institute of Psychiatry, Psychology and Neuroscience at King’s College, London, at a briefing on 12 July at London’s Science Media Centre.

Most of the new launches have been “tinkering with drugs which were really discovered in the ’50s and ’60s,” he explained. “Even the famous Prozac, which came in in the late ’80s, is really just a refinement of the tricyclic antidepressants that came in the ’50s. People say we are still in the age of steam, and we need to go to the next technological advance.”

Slow onset

In the past few years the focus has fallen on ketamine, which is used for pain relief and anaesthesia but is better known for being a horse sedative and a “club drug” that can induce hallucinations and calmness. It has been found to have rapid antidepressant effects and to be effective in many patients with treatment resistant depression.

US clinics increasingly offer IV infusions of ketamine off label, and in March esketamine, a nasal ketamine based drug, was approved by the US Food and Drug Administration for treatment resistant depression,1 at a cost of £32 400 (€36 060; $40 615) per patient per year.

Carlos Zarate, chief of the Experimental Therapeutics and Pathophysiology Branch at the US National Institute of Mental Health, who has been a key figure in the discovery and evaluation of ketamine as an antidepressant, said that one of the main problems with current antidepressants was their speed of onset in terms of antidepressant and anti-suicidal effects.

He explained that it took 10-14 weeks to see significant improvement with monoaminergic based antidepressants. “In my mind that is too slow,” he said. “We are focusing on treatments that can produce results within hours. That is where we are heading with the next generation of antidepressant, and ketamine is now the prototype for future generation antidepressants which will have rapid, robust antidepressant effects—rapid within a few hours.”

Efficacy and tolerability

Zarate said that, besides correcting chemical imbalances of serotonin and norepinephrine, the new generation of ketamine based antidepressants had other effects such as enhancing plasticity and restoring the synapses and dendrite circuits that shrivel in depression.

When ketamine is given to patients it binds to the N-methyl-D-aspartate (NMDA) receptor, causing a series of transient side effects including decreased awareness of the environment, vivid dreams, and problems in communicating. But the half life of ketamine is only two to three hours, so these side effects quickly subside, whereas the therapeutic effects of the drug last seven days or longer.

Zarate’s team is now focusing on the 24 metabolites of ketamine to hone the drug’s efficacy and tolerability. One of these, hydroxynorketamine, has already been shown to have similar antidepressive effects to ketamine in animals, without the side effects, and it is due to be tested in patients this autumn.

“Ketamine may actually be a prodrug for hydroxynorketamine,” said Zarate.

High cost

A few dozen patients with treatment resistant depression have been treated with ketamine in UK trials, and the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency are due to reach a decision on authorising esketamine for marketing in October. If the drug is approved private clinics will be able to provide it. But it would be unlikely to be available through the NHS until at least 2020, if at all, as the National Institute for Health and Care Excellence would need to deem it cost effective.

Rupert McShane, consultant psychiatrist and associate professor at the University of Oxford, said that, as well as the likely high cost of esketamine, patients treated with it must be observed in a clinic for two hours after each administration. This would require substantial clinical time, as esketamine is given twice a week for the first month, once a week for the second month, and once a week or once a fortnight from then on.

McShane also recommended that, if approved, a multidrug registry should be set up to monitor the long term safety and effectiveness of ketamine based drugs. Patients would be asked to input their use of any prescribed ketamine, esketamine, or any other future ketamine based product, as well as any self medication with illicit ketamine.

References


    1. Silberner J
    . Ketamine should be available for treatment resistant depression, says FDA panel. BMJ2019;364:l858.doi:10.1136/bmj.l858 pmid:30796014FREE Full TextGoogle Scholar

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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.”