First ‘gold-standard’ trial of ketamine’s anti-depressant effects launched

According to The Guardian, The first “gold standard” clinical trial of ketamine for the ongoing treatment of major depression was launched in Sydney on Tuesday and will involve seven research institutions and 200 patients from across Australia and New Zealand.

Several pilot studies have examined the effectiveness of ketamine for depression but these have typically been smaller studies testing a single dose of ketamine on acutely depressed patients.

These trials were necessary to establish whether the drug triggered a response in depressed patients and also to determine effective methods of administering it – for example, intravenously, nasally or subcutaneously. But no trial has been conducted to see how people respond to ongoing treatment with multiple doses of the drug compared with a placebo until now. The randomised double-blind trial – the gold standard for clinical research – means neither the researchers nor patients know whether they will be receiving ketamine or a placebo. The trial will run for three years.

Venn Diagram of Psychoactive Drugs

Prof Colleen Loo from the University of New South Wales, who is based at the Black Dog Institute in Sydney, is one of the study’s leaders and has been researching the use of ketamine to treat depression for more than five years.

“Existing studies show that if you give a single dose of ketamine to people with serious clinical depression, they do tend to get better – but that only lasts for a few days,” Loo said. “Feeling better for a few days is no good with a chronic disease like depression.

“What we now need to do is establish whether it can be used as an effective ongoing clinical treatment and, if so, who best responds to the treatment and what the treatment guidelines might be.

“It is not good enough to say that just because it has made people feel better in previous trials, when given one dose, that it is a safe and effective treatment long term.”

Loo said she was concerned that some clinicians were already prescribing ketamine to depressed patients. Currently, ketamine has only been approved by Australia’s Therapeutic Goods Administration for use as an anaesthetic but this does not prevent psychiatrists from prescribing it “off label” for depression.

“I know those doctors are running into problems because they call me for help, because what they are doing is entirely experimental and there is no evidence-based treatment protocol for them to follow,” Loo said.

“What happens is the patient responds to the ketamine, relapses after a few days, and so their doctor gives them another dose. As they get the treatment more and more it becomes less effective as people become resistant, so the doctor escalates the treatment. But after a while it just isn’t effective and the doctor is too scared to take their patient off the treatment in case it causes them to crash.

Read more at The Guardian

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