Cannabidiol for Bipolar Depression (CBD-BD)

Sponsor
University of British Columbia
Study ID
NCT05867849
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol — DRUG
    Cannabinoid
  • Placebo — OTHER
    Inactive substance

Study Details

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 its 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.

Key Dates

First listed
May 22, 2023
Start date
Oct 15, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cannabidiol
    Cannabidiol 200 - 600 mg / day added to current treatment for 6 weeks.
  • Placebo Comparator: Placebo
    Placebo added to current treatment for 6 weeks.

Primary Outcome Measure

Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy [ Time Frame: 6 weeks ]

Central Contacts

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