Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Bipolar Disorder Clinical Trial

— CBDBD  

Official title:

A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03310593
• Other study ID #: 63811317300005327
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 1, 2017
• Est. completion date: March 24, 2020

Study information

• Verified date: June 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Disease
• Mood Disorders

Intervention

Drug:
• Cannabidiol
Cannabidiol as active intervention.
• Placebo
Placebo intervention.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Evaluation of side effects according Udvalg for Kliniske Undersogelser (UKU) side effects rating scale.; Scale range: from 0 to 144.; Higher values represent more severe side effects associated to medications.	Up to weeks 08 and 12
Primary	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.	08 weeks
Secondary	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.	Up to weeks 08 and 12
Secondary	Improvement in anxiety symptoms	Change from baseline in Hamilton Anxiety Rating Scale (HAMA).; Scale range: from 0 to 56.; Higher values represent more severe symptoms of anxiety.	Up to weeks 08 and 12
Secondary	Improvement in functioning.	Change from baseline Functioning Assessment Short Test (FAST) scores.; Scale range: from 0 to 72.; Higher values represent more severe functional impairment.	Up to weeks 08 and 12
Secondary	Improvement in biological rhythms.	Improvement in biological rhythms according to Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN).; Scale range: from 0 to 88.; Higher values represent more severe symptoms of biological rhythms.	Up to weeks 08 and 12
Secondary	Change in BDNF levels in the blood.	Change in brain-derived neurotrophic factor (BDNF) levels in the blood.	Up to weeks 08 and 12
Secondary	Change in inflammatory levels in the blood.	Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein).	Up to weeks 08 and 12
Secondary	Change in endocannabinoid levels in the blood.	Change in endocannabinoid levels in the blood (anandamide and 2-arachidonoylglycerol).	Up to weeks 08 and 12
Secondary	Remission of manic symptoms.	Change from baseline in the Young Mania Rating Scale (YMRS) score.; Scale range: from 0 to 58.; Higher values represent more severe symptoms of mania.	Up to weeks 08 and 12
Secondary	Change in depressive symptoms	Change from baseline in Hamilton Depression Rating Scale (HAMD) score.; Scale range: from 0 to 52.; Higher values represent more severe symptoms of depression.	Up to weeks 08 and 12
Secondary	Change in psychotic symptoms	Change from baseline in Brief Psychiatric Rating Scale (BPRS) score.; Scale range: from 0 to 108.; Higher values represent more severe symptoms of psychosis.	Up to weeks 08 and 12
Secondary	Change in depressive symptoms according to MADRS	Higher values represent more severe symptoms of depression.; Scale range: from 0 to 60.	Up to week 12
Secondary	Change in depressive symptoms according to PHQ-9	Change from baseline in Patient Health Questionnaire (PHQ-9) score.; Scale range: from 0 to 27.	Up to weeks 08 and 12
Secondary	Change in oxidative stress markers levels in the blood.	Change in oxidative stress markers levels in the blood.	Up to weeks 08 and 12