Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Phase 3TerminatedNCT03310593

Hospital de Clinicas de Porto Alegre36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bipolar Disorder Bipolar Depression Bipolar Affective Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.

* Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. * Scale range: from 0 to 60. * Higher values represent more severe symptoms of depression.

Time frame: 08 weeks

Secondary Outcomes

Improvement in clinical global impression.

* Change from baseline in Clinical Global Impression(CGI-BP) scores. * Scale range: from 1 to 7. * Higher values represent more severe symptoms of bipolar disorder.