Cannabidiol
Cannabinoid
CBDLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-04-23
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Cannabinoid
CBDInactive substance
Eligibility
primary outcomes
Time frame: 6 weeks
The Montgomery Asberg Depression Rating Scale (MADRS) will be used to measure change in depressive symptoms from baseline to endpoint. Scores range from 0 to 60, and lower scores reflect better clinical outcomes.
secondary outcomes
Time frame: 6 weeks
Response rates are defined as patients showing ≥50% reduction in MADRS scores.
Time frame: 6 weeks
Remission rates are defined as MADRS ≤ 10 and YMRS ≤ 8 at endpoint.
Time frame: 6 weeks
The Young Mania Rating Scale (YMRS) will be used to determine the presence of any treatment-emergent manic or hypomanic events from baseline to endpoint. Scores range from 0 to 60, and lower scores reflect better clinical outcomes.
Time frame: 6 weeks
The 21-item Hamilton Depression Rating Scale (HAM-D 21) will be used to measure change in objective depressive symptoms from baseline to endpoint. Scores range from 0 to 62, and lower scores reflect better clinical outcomes.
Time frame: 6 weeks
The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) and the Dimensional Anhedonia Rating Scale (DARS) will be used to measure change in subjective depressive symptoms from baseline to endpoint. Lower scores on the QIDS-SR reflect better clinical outcomes; higher scores on the DARS reflect better clinical outcomes.
Time frame: 6 weeks
The Hamilton Anxiety Rating Scale (HAM-A) will be used to measure change in objective anxiety symptoms from baseline to endpoint. Scores range from 0 to 56 and lower scores reflect better clinical outcomes.
Time frame: 6 weeks
The State-Trait Anxiety Inventory (STAI) will be used to measure change in subjective anxiety symptoms. Lower scores on the STAI reflect better clinical outcomes.
Time frame: 6 weeks
The Generalized Anxiety Disorder 7-item (GAD-7) will be used to measure change in subjective anxiety symptoms. Lower scores on the GAD-7 reflect better clinical outcomes.
Time frame: 6 weeks
The Clinical Global Impression - severity \& change scales will be used to measure change in global severity and global improvement in symptoms from baseline to endpoint. Scores range from 3 to 42, and higher scores reflect worsening in overall psychiatric status.
Time frame: 6 weeks
The Positive and Negative Syndrome Scale (PANSS) will be used to measure change in psychotic symptoms from baseline to endpoint. Scores range from 7 to 49, and lower scores reflect better clinical outcomes.
Time frame: 6 weeks
The Cognitive Complaints in Bipolar Disorder Risk Assessment (COBRA) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function scale will be used to measure change in subjective cognitive functioning from baseline to endpoint. COBRA scores range from 0 to 48, and lower scores reflect better outcomes; PROMIS cognitive function scale scores range from 8 to 40, and higher scores reflect better outcomes.
Time frame: Week 6
The Screen for Cognitive Impairment in Psychiatry (SCIP) will be used to measure change in objective cognitive functioning from baseline to endpoint. Higher scores reflect better outcomes.
Time frame: 6 weeks
The Pittsburgh Sleep Quality Index (PSQI) will be used to measure changes in sleep quality and disturbance from baseline to endpoint. Lower scores reflect better sleep quality.
Time frame: 6 weeks
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to measure change in suicidal thoughts and behaviours from baseline to endpoint. Scores range from 0 to 37, and lower scores reflect better clinical outcomes.
Time frame: 6 weeks
The Brief Quality of Life in Bipolar Disorder (QoL.BD) will be used to measure change in quality of life from baseline to endpoint. Higher scores reflect higher quality of life.
Time frame: 6 weeks
The Functioning Assessment Short Test (FAST) will be used to measure change in daily functioning from baseline to endpoint. Lower scores reflect better daily functioning.
Time frame: 6 weeks
A healthcare utilization diary will be used to measure improvement in health services utilization from baseline to endpoint.
Time frame: 6 weeks
Adverse events will be measured objectively using an open-ended form and subjectively using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER). FIBSER scores range from 0 to 18, and lower scores reflect better outcomes.
Publications
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