Researchers at UBC’s Faculty of Medicine are launching a first-of-its-kind clinical trial investigating the potential of cannabidiol (CBD) as a treatment for bipolar depression.
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, there is a persistent unmet need for more effective and well-tolerated therapies.
The new trial, funded by the Canadian Institutes of Health Research (CIHR) and approved by Health Canada, will explore whether CBD can help manage acute bipolar depression alongside primary courses of treatment.
The trial is set to enroll approximately 360 participants spanning multiple sites across Canada, including the UBC Mood Disorders Centre, located at the Djavad Mowafaghian Centre for Brain Health (DMCBH) in Vancouver, as well as 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, DMCBH member, 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.”
CBD is a non-psychoactive compound found in cannabis plants. Despite evidence suggesting that CBD may have benefits for various mental and physical health conditions, no large clinical studies have been conducted to assess the safety and efficacy in bipolar depression.
In a pilot study published last year, UBC researchers demonstrated promising early results suggesting that CBD should be further studied in bipolar depression. The new trial aims to build on these findings, providing additional data on the safety and efficacy of CBD in a larger, national patient population.
“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 managing their symptoms and improving their overall quality of life.”
The 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 anticipates that the outcomes will contribute valuable insights to the development of novel and improved therapeutic options for people living with bipolar disorder.
For more information about the clinical trial or inquiries regarding participation, please contact bipolar.research@ubc.ca or call 604-822-8045.
A version of this story was originally published on the UBC Faculty of Medicine website.
