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临床试验/EUCTR2005-003196-21-DE
EUCTR2005-003196-21-DE进行中(未招募)1 期

Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil -a double blind, randomized, placebo-controlled, monocentric phase II study

Technische Universität München0 个研究点目标入组 30 人开始时间: 2006年4月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
30

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

性别
All

入选标准

  • Inpatients of the Psychiatric Hospital of the Technical University of Munich
  • - Depressive episode with somatic symptoms (ICD-10: F32.01, F32.11, F32.21)
  • - Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21)
  • - Bipolar affective disorder, presently depressive episode with somatic syndrome (F31.31, F31.41)
  • Age 18 – 70 years
  • Hamilton Depression Score (HAMD-21) at baseline > 18
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Presence of psychotic symptoms
  • Substance dependence (history or present)
  • Present psychiatric comorbidity
  • Relevant medical conditions
  • Acute suicidality
  • History of seizures
  • Paroxysmal EEG activity

研究者

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