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

Phase 2

Conditions: F31.3
F31.4
Bipolar affective disorder, current episode mild or moderate depression
Bipolar affective disorder, current episode severe depression without psychotic symptoms

Registration Number: DRKS00012657

Lead Sponsor: Charité - Universitätsmedizin Berlin, Campus Mitte

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 126

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

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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).<br>Changes in quality of life from baseline to week 8 of treatment as well as any other mid assessment (WHOQOL-BREF scale).<br>Changes in clinical global impression (CGI-BP) from baseline to week 8 of treatment as well as any other mid assessment <br><br>Safety und tolerability: <br>- Altman Self-Rating Mania Scala; Young Mania Rating Scale, incidence of mania requiring treatment<br>- Side Effects (Antidepressive Side Effekt Checklist, ASEC)<br>- Incidence of Adverse Events und SAE (and ADR, SADR)<br>- Blood pressure, Heart Rate, Laboratory Test, ECG, Weight