Cannabidiol as an Adjunctive Treatment for Bipolar Depression

NCT03310593 | Terminated Phase 2

• 1 other identifier: 63811317300005327
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Bipolar Depression; Bipolar Affective Disorder

Keywords

bipolar disorder; bipolar depression; cannabidiol; endocannabinoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Improvement in clinical global impression.

  Up to weeks 08 and 12

• Improvement in anxiety symptoms

  Up to weeks 08 and 12

• Improvement in functioning.

  Up to weeks 08 and 12

• Improvement in biological rhythms.

  Up to weeks 08 and 12

• Change in BDNF levels in the blood.

  Up to weeks 08 and 12

Other Outcomes (1)

• Side effects

  Up to weeks 08 and 12

Study Arms (2)

Cannabidiol

EXPERIMENTAL

Cannabidiol 150-300mg per day for 12 weeks.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Cannabidiol comparator for 12 weeks.

Drug: Placebo

Interventions

Cannabidiol DRUG

Cannabidiol as active intervention.

Cannabidiol

Placebo DRUG

Placebo intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

• Pinto JV, Crippa JAS, Cereser KM, Vianna-Sulzbach MF, Silveira Junior EM, Santana da Rosa G, Testa da Silva MG, Hizo GH, Simao Medeiros L, Santana de Oliveira CE, Bristot G, Campos AC, Guimaraes FS, Hallak JEC, Zuardi AW, Yatham LN, Kapczinski F, Kauer-Sant'Anna M. Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la depression bipolaire aigue : une etude pilote. Can J Psychiatry. 2024 Apr;69(4):242-251. doi: 10.1177/07067437231209650. Epub 2023 Nov 3.

  PMID: 37920963 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Márcia Kauer-Sant'Anna, MD, PhD

  Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized and placebo controlled study

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: October 16, 2017
• Study Start: November 1, 2017
• Primary Completion: February 24, 2020
• Study Completion: March 24, 2020
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)