Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective.

Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cannabidiol for Bipolar Depression (CBD-BD)

NCT05867849

Bipolar Disorder

RECRUITING PHASE3

Cannabinoids in Bipolar Affective Disorder

NCT00397605

Bipolar Affective Disorder

WITHDRAWN NA

Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

NCT05457465

Bipolar Disorder

RECRUITING PHASE2

Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers

NCT04231643

Bipolar Disorder

TERMINATED EARLY_PHASE1

Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder

NCT03206463

Delta-9-Tetrahydroncannabinol Bipolar Disorder Healthy Controls

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder Bipolar Depression Bipolar Affective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized and placebo controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cannabidiol

Cannabidiol 150-300mg per day for 12 weeks.

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol as active intervention.

Placebo

Cannabidiol comparator for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabidiol

Cannabidiol as active intervention.

Intervention Type DRUG

Placebo

Placebo intervention.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
* Young Mania Rating Scale (YMRS) ≤ 11.
* Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
* Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.

Exclusion Criteria

* Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
* Young Mania Rating Scale (YMRS) score \> 12.
* Current or past drug sensitivity/intolerance to cannabidiol.
* Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
* Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
* Any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs.
* Actively suicidal or homicidal risk.
* Females who are pregnant or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No