Ketamines defeat depression: Clinical trial results

A double-blind trial has shown promising results for a low-cost version of ketamine in treating severe depression, with more than 20% of participants experiencing complete remission of symptoms after a month of two-week injections. once.

A recent trial found that a low-cost version of ketamine was effective in treating severe depression, with more than 20% of participants achieving complete remission. The cost-effective treatment could revolutionize depression care, prompting researchers to advocate for broader adoption supported by Medicare.

A recent double-blind trial revealed promising effects of a low-cost version of ketamine in the treatment of major depression, compared with a placebo.

In the study published above British Journal of Psychiatry, researchers led by the University of New South Wales (UNSW Sydney) and its affiliated Black Dog Institute found that more than one-fifth of participants had complete remission of their symptoms one month after the injection every two weeks, while a third had improvements in their symptoms. at least 50 percent. The study was a collaboration between six clinical mood disorders research units in Australia and one in New Zealand and was funded by the Australian National Health and Medical Research Council (NHMRC).

Professor Colleen Loo, who led the study, said that for people with treatment-resistant depression, who do not benefit from different talking therapy modalities, antidepressants are often prescribed or therapy. electrocution, a 20% reduction is actually quite good.

We found that in this trial, ketamine was clearly better than placebo with 20% reporting no longer being clinically depressed compared to just 2% in the placebo group. This is a very large and very clear difference, and brings clear evidence to a field where previously there were only smaller trials comparing ketamine to placebo.

Judgment method

Researchers recruited 179 people with treatment-resistant depression. All were injected with a generic form of ketamine that is widely available in Australia as an anesthetic and sedative or a placebo. Participants received two injections per week at a clinic where they were monitored for approximately two hours while acute sedation and dissociation typically wore off within the first hour. The treatment lasted one month and participants were asked to rate their mood at the end of the trial and one month later.

As a double-blind trial, neither the participants nor the researchers administering the drugs knew which patients received ketamine or the original placebo, to ensure that psychological biases were minimized. Importantly, the placebo chosen also had a sedative effect, which improved treatment concealment. Midazolam is a sedative commonly used before general anesthesia, whereas in many previous studies the placebo was saline.

Professor Loo said that because saline has no subjective effect, in previous studies it was clear who received ketamine and who received placebo.

When using midazolam, which is not a treatment for depression but does make you feel a bit dizzy and so you are less likely to know if you are taking ketamine, which has similar acute use.

Other features of the recent trial that set it apart from previous studies include its acceptance of trial participants who had previously been treated with electroconvulsive therapy (ECT).

Professor Loo said people are recommended ECT for their depression when all other treatments have failed.

Most studies exclude people who have been treated with ECT because it is difficult for a new treatment to be effective without ECT.

Another difference in this trial is that the drug is delivered subcutaneously (injected into the skin) instead of through a drip, thereby significantly reducing time and medical complexity. This is also the largest study in the world to date comparing conventional ketamine with placebo in the treatment of major depression.

Cost-effectiveness of generic Ketamine

Besides the positive results, one of the notable benefits of using generic ketamine for treatment-resistant depression is that it is much less expensive than the patented S-ketamine nasal spray currently being marketed. used in Australia. While S-ketamine costs around $800 per dose, regular ketamine is a fraction of that, costing as little as $5, depending on the supplier and whether the hospital buys wholesale. In addition to medication costs, patients must also pay for the medical care they receive to ensure their experience is safe, at Black Dog Institute clinics this costs $350 per session .

With S-ketamine nasal spray, it will cost you about $1200 per treatment by the time you pay for the medication and procedure, while for regular ketamine, it will cost you about $300-350 for treatment including drug costs, Professor Loo said.

She adds that for both S-ketamine and conventional ketamine treatments, the positive effects typically wear off after a few days to a few weeks, so ongoing treatment may be necessary, depending on the situation. each person’s clinical condition. But the high cost of drugs and procedures makes this an unsustainable proposition for most Australians.

This is why we now apply for a Medicare category number to fund this treatment, because it is an effective treatment.

And if you consider that many of these people may be hospitalized for months or unable to work and are often suicidal, it’s quite cost-effective when you see it works quickly and powerfully. How strong is it? We have seen people return to work, school or leave the hospital because of this treatment in just a few weeks.

Next, researchers will look at larger trials of generic ketamine over longer periods of time and improve safety monitoring of the treatment.

Reference: Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for the treatment of treatment-resistant depression (KADS study): a randomized, double-blind, active-controlled trial of Colleen Loo, Nick Glozier, David Barton, Bernhard T. Baune, Natalie T. Mills, Paul Fitzgerald, Paul Glue, Shanthi Sarma, Veronica Galvez-Ortiz, Dusan Hadzi-Pavlovic, Angelo Alonzo, Vanessa Dong, Donel Martin, Stevan Nikolin, Philip B. Mitchell, Michael Berk, Gregory Carter, Maree Hackett, John Leyden, Sean Hood, Andrew A. Somogyi, Kyle Lapidus, Elizabeth Stratton, Kirsten Gainsford, Deepak Garg, Nicollette L.R. Thornton, Clia Fourrier, Karyn Richardson, Demi Rozakis, Anish Scaria, Cathrine Mihalopoulos, Mary Lou Chatterton, William M. McDonald, Philip Boyce, Paul E. Holtzheimer, F. Andrew Kozel, Patricio Riva-Posse and Anthony Rodgers, July 14, 2023, British Journal of Psychiatry.
DOI: 10.1192/bjp.2023.79

Funding: Australian National Health and Medical Research Council

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