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:
适应症
相关药物
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
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