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临床试验/EUCTR2010-024488-42-DK
EUCTR2010-024488-42-DK进行中(未招募)1 期

Pregabalin for anxiety comorbidity in patients with schizophrenia (PACS)- A Double-blinded Randomized Placebo Controlled Trial - PACS

Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Psychosisresearch0 个研究点目标入组 54 人开始时间: 2011年1月21日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
54

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

  • 1) Age 18-65 years
  • 2) An ICD-10 schizophrenia diagnosis F20.0-F20.3 or F20.9
  • 3) Fixed dose of psychotropics during the last 4 weeks before inclusion
  • 4) Hamilton Anxiety scale total score > 15
  • 5) Positive and Negative Syndrome Scale total score < 70
  • 6) The Calagary Depression Scale for Schizophrenia total score < 10
  • 7) For fertile women: Preganancy test negative and sexual abstinence or birth control methods during the study.
  • 8) S-creatinin within normal reference range.
  • 9) Signed informed constent and power attorney
  • 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 70
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1) Significant substance abuse
  • 2) QTc>480 ms
  • 3) Severe dysregulated diabetes
  • 4) For women: pregnancy or breast-feeding
  • 5) Retainment due to the mental health act.
  • 6) Concrete suicidalplans
  • 7) Known allergic to the trial drug

研究者

发起方
Aalborg University Hospital, Aalborg Psychiatric Hospital, Centre for Psychosisresearch

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