Last updated on December 2018

Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bipolar Disorder
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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