Bipolar DisorderPhase 3CBD-BDNCT05867849
Cannabidiol for Bipolar Depression (CBD-BD)
A Phase 3 study testing Cannabidiol in people with Bipolar Disorder, run by University of British Columbia at 6 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 6 sitesCanada
- Study dates
- 15 Oct 2023to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 19 to 70 years (inclusive).
- DSM-5 diagnosis of BD I or BD II, AND a current major depressive episode confirmed by MINI 7.0.2 .
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate; lamotrigine monotherapy as a mood stabilizer is acceptable for BD II patients only and not for BD I) OR an atypical antipsychotic OR a combination of these (two mood stabilizers or a mood stabilizer plus an atypical antipsychotic), at therapeutic doses. Medications and therapeutic doses are: lithium, serum level 0.6-1.2 mEq/L; divalproex/sodium valproate, serum level 350-700 uM/L(45-125 mcg/ml); risperidone 2-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; cariprazine 1.5-6 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day are also permitted.
- Have received a minimum of 6-weeks treatment at adequate doses for treatment of current depressive episode with at least one CANMAT recommended 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).
- A MADRS score of ≥ 20 and a YMRS score of ≤ 12 (these cut off scores are standard in bipolar depression RCTs).
- Inpatient or outpatient status.
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- All participants are required to agree to practice highly effective methods of contraception (i.e. hormonal contraceptives, intrauterine device or system, vasectomy and tubal ligation, or double barrier methods of contraception) OR agree to completely abstain from heterosexual intercourse. Females who do not have childbearing potential are required to be postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) OR surgically sterile.
- The capability of understanding, consenting to and complying with study requirements.
- All concomitant medication must be at a stable dose for two weeks prior to the randomization visit.
Who cannot join
- Current depressive episode greater than 12 months.
- A history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months.
- Current unstable or inadequately treated medical illness with the exception of current depression.
- Recently started taking a CANMAT-recommended treatment for the management of acute bipolar depressive episode, but has not had a trial for a minimum of 6 weeks with adequate doses.
- Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- Recently (i.e. within the past 8 weeks) started taking a stimulant medication. Concomitant treatment with stimulant medication is acceptable provided that the dose has been stable for a minimum of 8 weeks and is taken as prescribed by a physician.
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- Current use of clozapine, tricyclic antidepressants, monoamine oxidase inhibitors, and first-generation antipsychotics.
- A history of non-response or intolerance to CBD.
- Current or past month daily use of CBD, or any product or drug that contains CBD. Occasional users will be included if they agree to refrain from using during the trial.
- A history of non-response to electroconvulsive therapy for the current depressive episode.
- A current diagnosis of other primary psychiatric disorders as assessed by a study investigator to be primary and causing greater impairment than BD.
- A lifetime history of a primary psychotic disorder (e.g. schizoaffective disorder, bipolar subtype) according to DSM-5 criteria.
- Patients who have met the DSM-5 criteria for a substance use disorder (except for nicotine or caffeine) within the past 6 months.
- Significant active suicidal ideation (as evidenced by MADRS suicide item ≥ 4).
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario, L8N 3K7
Gomes Fabiano, MD
- Recruiting
Providence Care Hospital
Kingston, Ontario, K7L 4X3
Roumen Milev, MD
- Not yet recruiting
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
Serge Beaulieu, MD
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Ayal Schaffer, MD
- Not yet recruiting
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J1H4
Arun Ravindran, MD
Nisha Ravindran, MD
- Recruiting
UBC Mood Disorders Centre
Vancouver, British Columbia, V6T 1Z3
Shannon Reid, BA, 604-822-8045, shannon.reid@ubc.ca
Nazlin Walji, BSc, 604-822-7294, nazlin.walji@ubc.ca
About this study
Official title: Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial
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.
Read the 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 (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.
- Conditions
- Bipolar Disorder
- Being tested
- Cannabidiol, Placebo
- Keywords
- Cannabidiol, Bipolar Disorder, Bipolar Depression, Mood Disorder, CBD, Depression
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Cannabinoid
PlaceboOther
Inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Cannabidiol 200 - 600 mg / day added to current treatment for 6 weeks. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Placebo added to current treatment for 6 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy
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.
Measured: 6 weeks
Secondary outcomes (18)
Response rates
Response rates are defined as patients showing ≥50% reduction in MADRS scores.
Measured: 6 weeks
Remission rates
Remission rates are defined as MADRS ≤ 10 and YMRS ≤ 8 at endpoint.
Measured: 6 weeks
Treatment-emergent manic/hypomanic events
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.
Measured: 6 weeks
Objective depressive symptoms
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.
Measured: 6 weeks
Subjective depressive symptoms
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.
Measured: 6 weeks
Objective anxiety symptoms
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.
Measured: 6 weeks
Subjective anxiety symptoms assessed by STAI
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.
Measured: 6 weeks
Subjective anxiety symptoms assessed by GAD-7
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.
Measured: 6 weeks
Overall psychiatric status
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.
Measured: 6 weeks
Psychotic symptoms
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.
Measured: 6 weeks
Subjective cognitive functioning
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.
Measured: 6 weeks
Objective cognitive functioning
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.
Measured: Week 6
Sleep quality
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.
Measured: 6 weeks
Suicidal thoughts and behaviours
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.
Measured: 6 weeks
Quality of Life assessed by QoL.BD
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.
Measured: 6 weeks
Daily functioning
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.
Measured: 6 weeks
Health services utilization
A healthcare utilization diary will be used to measure improvement in health services utilization from baseline to endpoint.
Measured: 6 weeks
Adverse events
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start15 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lakshmi N Yatham, University of British Columbia
- Investigators
- Lakshmi N Yatham, MBBS, MRCPsy, Principal investigator, University of British Columbia, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867849
- Sponsor's protocol ID
- H23-00105
- Acronym
- CBD-BD
- Status last verified
- Apr 2025
- First submitted
- 9 May 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05867849
- Acronym / sponsor ID
- CBD-BD / H23-00105
- Conditions
- Bipolar Disorder
- Keywords
- Cannabidiol, Bipolar Disorder, Bipolar Depression, Mood Disorder, CBD, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolCannabidiol 200 - 600 mg / day added to current treatment for 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo added to current treatment for 6 weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females aged 19 to 70 years (inclusive).
- DSM-5 diagnosis of BD I or BD II, AND a current major depressive episode confirmed by MINI 7.0.2 .
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate; lamotrigine monotherapy as a mood stabilizer is acceptable for BD II patients only and not for BD I) OR an atypical antipsychotic OR a combination of these (two mood stabilizers or a mood stabilizer plus an atypical antipsychotic), at therapeutic doses. Medications and therapeutic doses are: lithium, serum level 0.6-1.2 mEq/L; divalproex/sodium valproate, serum level 350-700 uM/L(45-125 mcg/ml); risperidone 2-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; cariprazine 1.5-6 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day are also permitted.
- Have received a minimum of 6-weeks treatment at adequate doses for treatment of current depressive episode with at least one CANMAT recommended 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).
- A MADRS score of ≥ 20 and a YMRS score of ≤ 12 (these cut off scores are standard in bipolar depression RCTs).
Key exclusion criteria (16 listed)
- Current depressive episode greater than 12 months.
- A history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months.
- Current unstable or inadequately treated medical illness with the exception of current depression.
- Recently started taking a CANMAT-recommended treatment for the management of acute bipolar depressive episode, but has not had a trial for a minimum of 6 weeks with adequate doses.
- Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDCannabinoid | Drug | Cannabidiol |
| PlaceboInactive substance | Other | Placebo |
Primary outcome
Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy
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.
18 secondary outcomes
Response rates
Time frame: 6 weeks
Remission rates
Time frame: 6 weeks
Treatment-emergent manic/hypomanic events
Time frame: 6 weeks
Objective depressive symptoms
Time frame: 6 weeks
Subjective depressive symptoms
Time frame: 6 weeks
Objective anxiety symptoms
Time frame: 6 weeks
Subjective anxiety symptoms assessed by STAI
Time frame: 6 weeks
Subjective anxiety symptoms assessed by GAD-7
Time frame: 6 weeks
Overall psychiatric status
Time frame: 6 weeks
Psychotic symptoms
Time frame: 6 weeks
Subjective cognitive functioning
Time frame: 6 weeks
Objective cognitive functioning
Time frame: Week 6
Sleep quality
Time frame: 6 weeks
Suicidal thoughts and behaviours
Time frame: 6 weeks
Quality of Life assessed by QoL.BD
Time frame: 6 weeks
Daily functioning
Time frame: 6 weeks
Health services utilization
Time frame: 6 weeks
Adverse events
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lakshmi N Yatham, MBBS, MRCPsy principal investigator
University of British Columbia, Department of Psychiatry
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol in people with Bipolar Disorder, run by University of British Columbia at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazlin Walji, BSc (604-822-7294, nazlin.walji@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.