Cannabidiol as an Adjunctive Treatment for Bipolar Depression (CBDBD)

June 30, 2021 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cannabidiol
Cannabidiol 150-300mg per day for 12 weeks.
Drug: Cannabidiol
Cannabidiol as active intervention.
Placebo Comparator: Placebo
Cannabidiol comparator for 12 weeks.
Drug: Placebo
Placebo intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
Time Frame: 08 weeks
  • 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in clinical global impression.
Time Frame: Up to weeks 08 and 12
  • 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
Improvement in anxiety symptoms
Time Frame: Up to weeks 08 and 12
  • 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
Improvement in functioning.
Time Frame: Up to weeks 08 and 12
  • 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
Improvement in biological rhythms.
Time Frame: Up to weeks 08 and 12
  • 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
Change in BDNF levels in the blood.
Time Frame: Up to weeks 08 and 12
Change in brain-derived neurotrophic factor (BDNF) levels in the blood.
Up to weeks 08 and 12
Change in inflammatory levels in the blood.
Time Frame: Up to weeks 08 and 12
Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein).
Up to weeks 08 and 12
Change in endocannabinoid levels in the blood.
Time Frame: Up to weeks 08 and 12
Change in endocannabinoid levels in the blood (anandamide and 2-arachidonoylglycerol).
Up to weeks 08 and 12
Remission of manic symptoms.
Time Frame: Up to weeks 08 and 12
  • 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
Change in depressive symptoms
Time Frame: Up to weeks 08 and 12
  • 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
Change in psychotic symptoms
Time Frame: Up to weeks 08 and 12
  • 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
Change in depressive symptoms according to MADRS
Time Frame: Up to week 12
  • Higher values represent more severe symptoms of depression.
  • Scale range: from 0 to 60.
Up to week 12
Change in depressive symptoms according to PHQ-9
Time Frame: Up to weeks 08 and 12
  • Change from baseline in Patient Health Questionnaire (PHQ-9) score.
  • Scale range: from 0 to 27.
Up to weeks 08 and 12
Change in oxidative stress markers levels in the blood.
Time Frame: Up to weeks 08 and 12
Change in oxidative stress markers levels in the blood.
Up to weeks 08 and 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Up to weeks 08 and 12
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sao Paulo
Federal University of Rio Grande do Sul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Márcia Kauer-Sant'Anna, MD, PhD, Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 63811317300005327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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