Diamond Therapeutics has received approval from Health Canada to carry out a Phase 2 low-dose psilocybin trial for the treatment of generalised anxiety disorder (GAD) on a take-home basis.
The study will evaluate repeat low doses of psilocybin for safety, tolerability, and efficacy in treating generalised anxiety disorder (GAD), including an open-label follow-on extension.
According to Health Canada’s clinical trials database, this is the first study to treat patients suffering from generalised anxiety disorder with psychedelics.
Chief Medical Officer of Diamond, Dr Michael McDonnell, commented: “Building on the results of Diamond’s completed Phase I clinical trial, which established a safe, tolerable, non-hallucinogenic range for the use of low doses of psilocybin on an outpatient basis, this Phase 2 trial will explore the subjective and cognitive effects of low doses of psilocybin as well as effects on quality of life in adults who meet the criteria for GAD.”
GAD affects 6.8 million adults annually in the US, or about 3.1% of the population, yet only an estimated 43.2% of them receive treatment.
Patients with GAD experience considerable impairment and disability, similar to major depression, with which GAD often co-occurs. As a result, GAD is associated with a significant economic burden owing to decreased work productivity and increased use of health care services, particularly primary health care.
CEO of Diamond, Judy Blumstock, commented: “We are grateful for Health Canada’s approval of Diamond’s latest clinical trial application, which brings us closer to our goal of developing psilocybin-based medicines that are safe and effective for patients, that are better than the current first-line, and that may be prescribed on an outpatient basis, removing the barrier of lengthy time spent in a clinic.”
