Dr. Josh Rosenblat, chief medical and science officer of Toronto-based Braxia Scientific, has been awarded funding by the Canadian Institute of Health Research (CIHR) to support a first-of-its-kind ketamine clinical trial for bipolar depression, the company has announced.

The fully funded study, which the company claims is the largest registered trial of its kind in the world, will investigate the use, safety and efficacy of repeated doses of intravenous ketamine in patients with bipolar depression.

Just under three per cent of Canadians have a profile consistent with bipolar disorder, according to Statistics Canada. It is a leading cause of treatment-resistant depression and suicidality.

The trial will include 100 patients across two sites, Toronto’s University Health Network and Braxia’s CRTCE Research Clinic, with the goal of further advancing intravenous ketamine as a safe, effective and rapid-acting treatment.

In May, Braxia opened its first ketamine therapy clinic in Quebec, in a joint venture with Neurotherapy Montreal, which has a network of more than 1,200 psychiatrists across the province.

The facility is the fourth clinic that Braxia has opened in Canada and is the first private clinic in Quebec to offer ketamine therapy.

According to Dr. Roger McIntyre, CEO of Braxia and a professor of psychiatry and pharmacology at the University of Toronto, Braxia has administered more than 3,000 intravenous ketamine infusions and over 60 intranasal ketamine treatments in the past three years.

“These treatments have shown highly significant rapid-acting efficacy to patients with depression,” Dr. McIntyre said in May. “Many of our patients have experienced substantial relief for what often can be debilitating depression and suicidal thinking.”

Ketamine, a dissociative psychedelic, has been legally used as an anesthetic since the 1970s and is used in Canada as a doctor-prescribed, off-label treatment for treatment-resistant depression.

In May 2020, Health Canada approved intranasal esketamine (SPRAVATO) for the treatment of “major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.”