DRKS00012657尚未招募2 期
Cannabidiol in Bipolar Depression – An 8-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Cannabidiol as Add-on Therapy in Bipolar Depression - CannaBiD
Charité - Universitätsmedizin Berlin, Campus Mitte0 个研究点目标入组 126 人开始时间: 2017年7月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •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
排除标准
- •- 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)
研究者
相似试验
已完成
4 期
A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia SyndromeMajor DepressionNCT00675896Dr Alexander McIntyre Inc.120
招募中
不适用
A 8-week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KBL396 on improvement of Sleep quality in adults with Sleep disorders, Stress, Anxiety, and DepressioKCT0006865Kobiolabs105
招募中
不适用
Efficacy of LTC-022 on Sleep ImprovementKCT0007750Korea Institute of Oriental Medicine40
进行中(未招募)
不适用
An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study toEvaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as AdjunctiveTherapy in Adults With Major Depression Associated WithBipolar I DisorderMajor Depression Associated With Bipolar I DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionEUCTR2007-007555-14-HUCephalon, Inc.240
进行中(未招募)
不适用
An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study toEvaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as AdjunctiveTherapy in Adults With Major Depression Associated WithBipolar I DisorderMajor Depression Associated With Bipolar I DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionEUCTR2007-007555-14-BGCephalon, Inc.240
