Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867849
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-05-09
Brief Title:
Cannabidiol for Bipolar Depression CBD-BD
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Cannabidiol Adjunctive Therapy for Acute Bipolar Depression A Randomized Double-Blind Placebo Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBD-BD
Brief 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
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
Detailed 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 ie lithium lamotrigine lurasidone or quetiapine either as monotherapy or adjunctive therapy or at least one first or second-line treatment for bipolar II depression ie 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 andor atypical antipsychotic as prescribed by their treating physicians
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 andor atypical antipsychotic as prescribed by their treating physicians
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None