Status:
TERMINATED
Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Federal University of Rio Grande do Sul
University of Sao Paulo
Conditions:
Bipolar Disorder
Bipolar Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 cann...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03310593
Start Date
November 1 2017
End Date
March 24 2020
Last Update
July 2 2021
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903