Researchers at UBC’s faculty of medicine are launching a new, unique clinical trial to investigate the potential of cannabidiol (CBD) as a treatment for bipolar depression.

The new trial is funded by the Canadian Institutes of Health Research (CIHR) and approved by Health Canada. The goal of the research will be to investigate if CBD can help manage acute bipolar depression alongside primary courses of treatment.

The trial will enroll approximately 360 participants spanning multiple sites across Canada, including the UBC Mood Disorders Centre in Vancouver, BC, and sites in Ontario, Quebec and Nova Scotia.

“Bipolar disorder is a complex condition, with depression often posing the greatest burden for patients,” says Dr. Lakshmi Yatham, professor and head of UBC’s Department of Psychiatry and the study’s principal investigator. “This trial marks a significant step forward in exploring innovative, much-needed treatments for bipolar disorder.”

Bipolar disorder is a chronic mental health condition characterized by extreme changes in mood that cycle through periods of intense highs (mania) and lows (depression). Depressive episodes present a considerable challenge for people living with the condition and are associated with feelings of sadness and hopelessness, loss of interest in activities, trouble sleeping, and increased risk of suicide. Despite available treatments, a persistent unmet need exists for more effective and well-tolerated therapies.

The new trial will explore whether CBD can help manage acute bipolar depression alongside primary courses of treatment.

No large clinical studies have been conducted to assess the safety and efficacy of CBD in treating bipolar depression.

In a small pilot study published last year, UBC researchers found that CBD did not show significantly higher adverse effects than placebo. Despite this, an exploratory analysis also suggested that cannabidiol should be further studied in bipolar depression in higher doses of at least 300 mg/day and under research designs that could better control for high placebo response.

“Our pilot trial showed signals for efficacy of CBD which provided an impetus for this large trial,” says Dr. Yatham. “If proven effective, this has the potential to provide significant benefits to patients by helping effectively manage their symptoms and improving their overall quality of life.”

This new, randomized, double-blind, placebo-controlled study will evaluate the safety, efficacy and tolerability of a CBD product (ProZ-001) manufactured and supplied by PBG Biopharma Inc.

The research team says they anticipate that the outcomes will provide valuable insights into the development of novel and improved therapeutic options for people living with bipolar disorder.

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