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Cannabidiol as an Adjunctive Treatment for Bipolar Depression (CBDBD)

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ClinicalTrials.gov Identifier: NCT03310593
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
University of Sao Paulo
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. [ Time Frame: Up to 12 weeks ]
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
Change History Complete list of historical versions of study NCT03310593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Improvement in clinical global impression. [ Time Frame: Up to 12 weeks ]
    Change from baseline in Clinical Global Impression(CGI-BP) scores.
  • Improvement in anxiety symptoms [ Time Frame: Up to 12 weeks ]
    Change from baseline in Hamilton Anxiety Rating Scale (HAMA).
  • Improvement in functioning. [ Time Frame: Up to 12 weeks ]
    Change from baseline Functioning Assessment Short Test (FAST) scores.
  • Improvement in biological rhythms. [ Time Frame: Up to 12 weeks ]
    Improvement in biological rhythms according to Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN).
  • Change in BDNF levels in the blood. [ Time Frame: Up to 12 weeks ]
    Change in brain-derived neurotrophic factor (BDNF) levels in the blood.
  • Change in inflammatory levels in the blood. [ Time Frame: Up to 12 weeks ]
    Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein).
  • Change in endocannabinoid levels in the blood. [ Time Frame: Up to 12 weeks ]
    Change in endocannabinoid levels in the blood.(anandamide and 2-arachidonoylglycerol).
  • Remission of manic symptoms. [ Time Frame: Up to 12 weeks ]
    Change from baseline in the Young Mania Rating Scale (YMRS) score.
  • Change in depressive symptoms [ Time Frame: Up to 12 weeks ]
    Change from baseline in Hamilton Depression Rating Scale (HAMD) score and in Patient Health Questionnaire (PHQ-9).
  • Change in psychotic symptoms [ Time Frame: Up to 12 weeks ]
    Change from baseline in Brief Psychiatric Rating Scale (BPRS) score.
  • Change in depressive symptoms [ Time Frame: Up to 12 weeks ]
    Change from baseline in Patient Health Questionnaire (PHQ-9) score.
Current Other Pre-specified Outcome Measures
 (submitted: December 14, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: October 13, 2017)
Side effects [ Time Frame: Up to 12 weeks ]
Evaluation of side effects according Udvalg for Kliniske Undersogelser (UKU) side effects rating scale.
 
Descriptive Information
Brief Title  ICMJE Cannabidiol as an Adjunctive Treatment for Bipolar Depression
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, randomized and placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Bipolar Depression
  • Bipolar Affective Disorder
Intervention  ICMJE
  • Drug: Cannabidiol
    Cannabidiol as active intervention.
  • Drug: Placebo
    Placebo intervention.
Study Arms  ICMJE
  • Experimental: Cannabidiol
    Cannabidiol 150-300mg per day for 12 weeks.
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    Cannabidiol comparator for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Márcia Kauer-Sant'Anna, MD, PhD +55 51 3359 8845 mksantanna@gmail.com
Contact: Jairo Vinícius Pinto, MD +55 51 3359 8021 jairovinicius@msn.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310593
Other Study ID Numbers  ICMJE 63811317300005327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE
  • Federal University of Rio Grande do Sul
  • University of Sao Paulo
Investigators  ICMJE
Study Chair: Márcia Kauer-Sant'Anna, MD, PhD Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP