Trial document




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  DRKS00012657

Trial Description

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Title

Cannabidiol in Bipolar Depression –
An 8-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Cannabidiol as Add-on Therapy in Bipolar Depression

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Trial Acronym

CannaBiD

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The objective of this clinical trial is to evaluate the potential use of Cannabidiol in the treatment of acute bipolar depression. Recent neurobiological studies have shown that the endocannabinoid system plays a role in the regulation of the body’s homeostasis. There is also evidence, that the endocannabinoid system is involved in the brain’s stress controlling system, cognition, and emotion. Cannabidiol appears to have a modulating effect on the endocannabinoid system. Animal studies have shown Cannabidiol to have antidepressant- and anxiolytic-like effects. Clinical studies have provided evidence that Cannabidiol is well tolerated. The purpose of this 8-week randomized, double-blind, placebo-controlled clinical trial is to evaluate the efficacy and tolerability of Cannabidiol as an add-on therapy in bipolar depression. Cannabidiol is investigated as add-on therapy to an already existing mood stabilizing therapy. The main hypotheses are as follows: In the patient group treated with Cannabidiol there is a significantly greater mean improvement of depressive symptoms, anxiety symptoms and quality of life from baseline to week 8 of treatment than in the placebo group. Treatment with Cannabidiol is safe and tolerated well. In the patient group treated with Cannabidiol, incidence of manic symptoms from baseline to week 8 of treatment is not significantly higher than in the placebo group.

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Organizational Data

  •   DRKS00012657
  •   2017/07/19
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  •   yes
  •   Approved
  •   15/0532 - EK 13, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2015-000465-31 
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Health Condition or Problem studied

  •   F31.3 -  Bipolar affective disorder, current episode mild or moderate depression
  •   F31.4 -  Bipolar affective disorder, current episode severe depression without psychotic symptoms
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Interventions/Observational Groups

  •   Arm 1: Cannabidiol 400mg/day p.o. (2 capsules) in addition to therapy with mood stabilizer or neuroleptic medication for 56 days. Starting in week 2 of treatment, dose increases up to 600mg are possible.
  •   Placebo 400mg/day p.o. (2 capsules) in addition to therapy with mood stabilizer or neuroleptic medication for 56 days. Starting in week 2 of treatment, dose increases up to 600mg (3 capsules) are possible.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Mean changes in depressive symptoms from baseline to week 8 of treatment measured with the HDRS-17 scale (Hamilton Depression Rating Scale-version: 17 items)

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Secondary Outcome

Changes in depressive symptoms from baseline to week 8 of treatment and any other mid assessment respectively using further questionnaires (MADRS; BDI II; BDRS; HAMA ; STAI-State).
Changes in quality of life from baseline to week 8 of treatment as well as any other mid assessment (WHOQOL-BREF scale).
Changes in clinical global impression (CGI-BP) from baseline to week 8 of treatment as well as any other mid assessment

Safety und tolerability:
- Altman Self-Rating Mania Scala; Young Mania Rating Scale, incidence of mania requiring treatment
- Side Effects (Antidepressive Side Effekt Checklist, ASEC)
- Incidence of Adverse Events und SAE (and ADR, SADR)
- Blood pressure, Heart Rate, Laboratory Test, ECG, Weight

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/08/01
  •   126
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- male and female patients between 18 – 65 years
- Bipolar Depression (DSM-IV)
- Hamilton-Rating-Depression-Scale-17 > 17
- stable optimized treatment with at least one medication for long term treatment of bipolar disorder according to the German S3-guidelines, sufficient dosage
- YMRS < 12
- written informed consent
- capability to give informed consent
- negative pregnancy test
- highly effective method of contraception

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Exclusion Criteria

- pregnant or nursing women
- serious suicidal risk or harm for others
- inpatient treatment by legal order (PsychKG/BGB)
- psychotic features or rapid cycling
- relevant psychatric comorbidity such as dementia, delir, alcohol or illicit substance dependency with ongoing consumption, history of schizophrenia/ schizoaffective disorder, mental retardation
- current treatment with antidepressive agents that cannot be discontinued
- Treatment with quetiapine
- non compensated thyroid disease
- any clinical significant medical condition which will be considered “unstable”
- a known hepatitis type B/C, a known HIV infection, a known malignant disorder
- missing contraception for men and women
- a known intolerance to Cannabinoids
- receiving therapy with a strong CYP3A4 inductor or inhibitor (e.g. carbamazepine)

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Addresses

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    • Charité - Universitätsmedizin Berlin, Campus Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie, Psychiatrische Institutsambulanz, Campus Mitte
    • Mr.  Dr. med.  Johannes  Rentzsch 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie, Psychiatrische Institutsambulanz, Campus Mitte
    • Mr.  Dr.med.  Johannes  Rentzsch 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Stanley Medical Research Institute
    • 10605 Concord Street, Suite 206
    • 20895  Kensington
    • United States
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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