Cannabidiol as an Adjunctive Treatment for Bipolar Depression

• Status: Terminated
• Trial end date: 2020-03-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul; University of Sao Paulo
• Treatments: Cannabidiol

Criteria

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