EUCTR2010-022307-22-NO进行中（未招募）1 期
The Bergen Psychosis Project 2 - BP2
Haukeland University Hospital, Division of Psychiatry0 个研究点目标入组 400 人开始时间: 2011年4月11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
- 400
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
- •a) Patients 18 years and more with symptoms of active psychosis as determined by a score of 4 or more on one or more of the items Delusions, Hallucinatory behavior, Grandiosity, Suspiciousness/ persecution, or Unusual thought content in the Positive and Negative Syndrome Scale (PANSS).
- •b) Fullfilling the diagnostic criteria for one or more of the following ICD-10 diagnoses:
- •F10.5, F11.5, F12.5, F13.5, F14.5, F15.5, F16.5, F17.5, F18.5, F19.5; F20-29.
- •c) Antipsychotic drug therapy indicated using the oral formulation of the drugs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •a) Diagnosis of affective psychosis
- •b) Unable to comply with study protocol
- •c) Does not understand the language spoken at the investigation site.
- •d) Patients with organic psychosis due to limbic encephalitis
- •e) Pregnant or breast feeding women
- •f)Hypersensitivity to active ingredient or any of the excipients
- •g) Prolactin-dependent tumours
- •h) Use of drugs which could induce torsade de pointes
- •i) Phaeochromocytoma
- •j) Use of levodopa
- •k) Known risk of narrow-angle glaucoma
研究者
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