ISRCTN02658871已完成未知
Secondary PREVENTion of schizophrenia: a randomised controlled trial
niversity of Cologne (Germany)0 个研究点目标入组 300 人开始时间: 2007年12月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
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
- •Current participant inclusion criteria as of 19/03/2019:
- •1. Aged between 18 - 49 years
- •2. Belong to one of the following groups:
- •2.1. Attenuated Positive Symptoms (APS)
- •2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS)
- •2.3. Predictive basic symptoms
- •2.4. Family risk plus reduced functioning
- •3. Verbal Intelligence Quotient (IQ) greater than 70
- •4. Written informed consent
- •Previous participant inclusion criteria:
- •1. Aged between 18 - 40 years
- •2. Belong to one of the following groups:
- •2.1. Attenuated Positive Symptoms (APS)
- •2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS)
- •2.3. Predictive basic symptoms
- •2.4. Family risk plus reduced functioning
- •3. Verbal Intelligence Quotient (IQ) greater than 70
- •4. Written informed consent
排除标准
- •1. Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- •2. Present or past diagnosis of a brief psychotic disorder according to DSM IV with a duration equal to or of more than one week or within the last 4 weeks regardless of its duration
- •3. Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation, autism spectrum disorders, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV
- •4. Alcohol or drug dependence according to DSM IV
- •5. Diseases of the central nervous system (inflammatory, traumatic, epilepsy etc.)
- •6. Magnetic Resonance Imaging (MRI) or Electroencephalogram (EEG) abnormalities
- •7. Current or past antipsychotic treatment for longer than 1 week
- •8. Current or past antipsychotic treatment shorter than 1 week without a washout phase of at least 4 weeks
- •9. Current pregnancy, lactation or missing reliable method of contraception
- •10. Current suicidality or dangerous behaviour
- •11. Contraindication according to Summary of Product Characteristics (SmPC): known intolerance of the active pharmaceutical ingredient or another ingredient of verum or placebo
- •12. Use of drugs with anticipated interactions (in accordance to SmPC)
- •13. Participance in other clinical trials, which could intervene with the present trial
- •14. Persons who are depending on the investigator or the sponsor
- •15. Hospitalisation due to legal or regulatory devices
研究者
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