Cannabidiol for Bipolar Depression (CBD-BD) — CBD-BD  

Bipolar Disorder Clinical Trial

Official title: Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial

Status Recruiting

Clinical Trial Summary

Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of depression and (hypo) mania. Periods of chronic and recurring depressive episodes are more common and can be severely disabling. Effective treatments exist; however, a significant portion of bipolar depressed patients do not respond to or have difficulty tolerating many of these interventions and thus look beyond established treatments to achieve symptom relief.

Cannabidiol (CBD), a chemical from the Cannabis sativa plant has shown to have some beneficial effects on mood symptoms in a few small studies which assessed its effects in other mental and physical health conditions, but no large studies have been conducted to assess the safety and efficacy in bipolar depression. Additionally, several clinical studies have shown CBD to be safe and tolerable.

The primary objective of this study is to assess the effectiveness, safety and tolerability of Cannabidiol in patients with bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar depression in comparison to those who will be treated with placebo. Placebo is an inactive substance that looks identical to the study medication but contains no therapeutic ingredient. This study is a randomized (like the flip of a coin), double-blind (you and the study team will not know which treatment arm you receive) study in which participants will receive either CBD or placebo added to their current treatment. Participants will have 5 clinical appointments and a phone appointment over a period of 10 weeks.

Clinical Trial Description

This is a Phase 3, 6-week, double-blind, parallel group randomized controlled trial to assess the efficacy, safety and tolerability of adjunctive CBD vs placebo in patients with acute bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar I disorder (i.e. lithium, lamotrigine, lurasidone, or quetiapine either as monotherapy or adjunctive therapy), or at least one first or second-line treatment for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). After the baseline visit, patients who meet the eligibility criteria will enter a 6-week double-blind treatment phase during which participants will be randomized to adjunctive CBD or identical placebo.

Participants will be assessed at the screening visit, baseline visit, weeks 2, 4, and 6, or endpoint visit. All participants will receive a follow-up telephone call 2 weeks after the 6-week study endpoint or early termination visit to assess well-being.

All participants will continue treatment with their mood stabilizer and/or atypical antipsychotic as prescribed by their treating physicians. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

• NCT number: NCT05867849
• Study type: Interventional
• Source: University of British Columbia
• Contact: Nazlin Walji, BSc
• Phone: 604-822-7294
• Email: nazlin.walji@ubc.ca
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2023
• Completion date: December 2030