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临床试验/DRKS00012657
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

发起方
Charité - Universitätsmedizin Berlin, Campus Mitte

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