Clinical trial NCT03310593: Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Bipolar Disorder
Bipolar Depression
Bipolar Affective Disorder
Keywords: bipolar disorder
bipolar depression
cannabidiol
endocannabinoids
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: University of Sao Paulo
First posted: 2017-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized and placebo controlled study
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
timeFrame: 08 weeks
Secondary outcomes:
measure: Improvement in clinical global impression.
timeFrame: Up to weeks 08 and 12
measure: Improvement in anxiety symptoms
timeFrame: Up to weeks 08 and 12
measure: Improvement in functioning.
timeFrame: Up to weeks 08 and 12
measure: Improvement in biological rhythms.
timeFrame: Up to weeks 08 and 12
measure: Change in BDNF levels in the blood.
timeFrame: Up to weeks 08 and 12
measure: Change in inflammatory levels in the blood.
timeFrame: Up to weeks 08 and 12
measure: Change in endocannabinoid levels in the blood.
timeFrame: Up to weeks 08 and 12
measure: Remission of manic symptoms.
timeFrame: Up to weeks 08 and 12
measure: Change in depressive symptoms
timeFrame: Up to weeks 08 and 12
measure: Change in psychotic symptoms
timeFrame: Up to weeks 08 and 12
measure: Change in depressive symptoms according to MADRS
timeFrame: Up to week 12
measure: Change in depressive symptoms according to PHQ-9
timeFrame: Up to weeks 08 and 12
measure: Change in oxidative stress markers levels in the blood.
timeFrame: Up to weeks 08 and 12
Other outcomes:
measure: Side effects
timeFrame: Up to weeks 08 and 12
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre
name: Márcia Kauer-Sant'Anna, MD, PhD
role: STUDY_CHAIR
References: