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Cannabidiol as an Adjunctive Treatment for Bipolar Depression

NCT03310593 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-07-02

No results posted yet for this study

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

Interventions

DRUG

Cannabidiol

Cannabidiol as active intervention.

DRUG

Placebo

Placebo intervention.

Sponsors & Collaborators

  • Federal University of Rio Grande do Sul

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Márcia Kauer-Sant'Anna, MD, PhD · Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-02-24
Completion
2020-03-24

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03310593 on ClinicalTrials.gov