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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

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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Bipolar Affective Disorder Drug: Cannabidiol Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  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.

  13. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310593


Contacts
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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

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
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   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
University of Sao Paulo
Investigators
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Study Chair: Márcia Kauer-Sant'Anna, MD, PhD Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03310593     History of Changes
Other Study ID Numbers: 63811317300005327
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
bipolar disorder
bipolar depression
cannabidiol
endocannabinoids
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Bipolar Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders
Epidiolex
Anticonvulsants