ISRCTN13032035已完成不适用
Phase III study to prove the efficacy, safety and tolerability of Silexan® in patients with anxiety disorder
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 220 人开始时间: 2008年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age range: 18 - 65, both males and females
- •2. Primary diagnosis of an anxiety disorder NOS according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; 300.00)
- •3. Severity of anxiety for the inclusion: the Hamilton Anxiety Scale (HAM-A) total score >=18, Item 1 anxious mood >=2, Item 2 insomnia >=2
- •4. Severity of sleep disorders for the inclusion: Pittsburgh Sleep Quality Index (PSQI) total score >5
排除标准
- •1. A decrease of 25% or more of the HAM-A total score during the screening phase
- •2. Any clinically important psychiatric or neurological diagnoses other than an anxiety disorder NOS within 6 month before the study
- •3. Risk of suicide
- •4. History or evidence of alcohol and/or substance abuse or dependence
- •5. Current use of other psychotropic drugs
- •6. Any unstable acute medical disorder
- •7. Prohibited concomitant treatment: any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquiliser, antidepressives, antiepileptics, antihistaminics
- •8. Long-term prophylactic treatment
- •9. Central-acting antihypertensive medication
- •10. Anti-Parkinson's medication
- •11. Phyto-anxiolytics
- •12. Muscle relaxants
- •13. Analgetics of opiate type
- •14. Anaesthetics
- •15. Barbiturates
- •16. Nootropics
- •17. Non-medical psychiatric treatment
研究者
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