Bipolar disorder, current episode depressed MedDRA version: 19.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 19.0 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders M
Conditions
Interventions
Product Name: Cannabidiol
Product Code: CBD
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female in- and outpatients between 18 – 65 years with a Bipolar Disorder (DSM-V) and a current acute depressive episode (HDRS-17 > 17) with no current manic symptoms (YMRS =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - pregnant or nursing women - a clinically significant medical illness - a current psychiatric disorder which is the primary focus of treatment other than Bipolar Disorder - current treatment with quetiapine - current diagnosis or history of schizophrenia/ schizoaffective disorder, mental retardation, organic mental disorder, or mental disorder due to a general medical condition - current diagnosis or history of alcohol or other substance abuse/ dependency (excluding nicotine or caffeine) that has not been in full and sustained remission for at least 3 month - any Axis II disorder that might compromise the study - serious suicidal risk or harm for others; - a current bipolar disorder with psychotic features - a current history of rapid cycling - any medical condition which will be defines as “unstable”, which means that a clinical relevant change within the next 8 weeks has to be considered - any medical diagnostic intervention which results will give reasons for the beginning of a pharmacological or surgical therapy which have to start within the next 8 weeks - planed krankenhausaufenthalt within the study period - non-compensated hypo- or hyperthyreosis - inpatient treatment by legal order - known hepatitis type B or C, a known HIV infection or known maligne disorder - any patients which will not agree to the given birth control method - cannabinoide intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of CBD compared to placebo as add-on treatment to mood-stabilizers in the treatment of patients with an acute episode of bipolar depression in the reduction of depressive symptoms after 8 week of treatment. ; Secondary Objective: Efficacy of CBD add-on treatment compared to placebo in: - reduction of symptoms of anxiety after 8 week of treatment. - in improvement of quality of life after 8 week of treatment. - in reduction of self-rated depressive symptoms after 8 week of treatment. - in the overall clinical improvement (CGI-BP) of depression after 8 week of treatment. - Number of patients in early improvement, response or remission (wk 2, wk 4, wk 8). - Improvement of depressive symptoms and symptoms of anxiety to any timepoint Safety: manic symptoms and mania requiring treatment; adverse events ; Primary end point(s): change in HDRS-17 score ;Timepoint(s) of evaluation of this end point: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - mean scores in HDRS-6, MADRS, STAI, HAMA, BDI-II, WHOQOL-BREF - early improvement (30% reduction), response (50% reduction), remitters (HDRS-17 < 8 or MADRS < 11) - Safety: manic symptoms (YMRS, AMI); mania requiring treatment; Antidepressant Side-Effect Checklist; Hematology tests and Clinical chemistry; ECG; Blood pressure; Heart rate; Body weight ; Timepoint(s) of evaluation of this end point: - mean scores: week 8 and any time point - early improvement week 2, response week 4 or 8, remitters week 4 or week 8 - Safety: any time point | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Charité - Universitätsmedizin Berlin
Outcome results
None listed