EUCTR2015-000465-31-DE进行中（未招募）1 期
Cannabidiol in Bipolar Depression – CannaBiD-Study: An 8-week randomized, double-blind, placebo-controlled clinical trial of Cannabidiol as add-on therapy in bipolar depression - CannaBiD-Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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 < 12)
- •- no treatment with any antidepressant agent (i.e. any medication which is licensed as monotherapy for the treatment of unipolar depression) within the last 2 weeks
- •- written informed consent
- •- ability to understand and comply with the requirements of the study
- •- capability to give informed consent
- •- Women: negative serum human chorionic gonadotropin
- •- highly effective method of contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 106
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- 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
研究者
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