ISRCTN65259480已完成不适用
Randomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression
Ministry of Health (Czech Republic) - Internal Grant Agency0 个研究点目标入组 60 人开始时间: 2010年9月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0.
- •2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997
- •3. The mental ability to understand and sign Informed Consent Form
- •4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4
- •5. Outpatients and inpatients
- •6. Age between 18 and 65 years
排除标准
- •1. Contraindications of used antidepressant treatments according to Summary of product (SPC)
- •2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode
- •3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy
- •4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study
- •5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study
研究者
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