A multicentre randomised interventional trial of the clinical and cost-effectiveness of citalopram versus placebo in the management of negative symptoms of schizophrenia

Imperial College London (UK)0 个研究点目标入组 360 人开始时间: 2010年5月12日最近更新: 2016年10月17日

适应症

试验速览

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•1. An Operational Criteria Checklist for Psychosis (OPCRIT) diagnosis of schizophrenia, schizophreniform, schizoaffective disorder or psychosis not otherwise specified (NOS) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
•2. A negative subscale score of 20 or more on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). At least three of the seven items on the negative symptom subscale should be rated 3 or more. Negative symptoms that reflect, sometimes very subtly, manifestations of depressive symptoms, antipsychotic side effects such as bradykinesia, or positive symptoms, are referred to as secondary negative symptoms, and the assessors will attempt to distinguish these from primary negative symptoms. However, persistent negative symptoms will be used as an inclusion criterion rather than primary negative symptoms, as the former are the clinically-relevant target, and the latter represent a hypothesis about aetiology that cannot be definitely determined on cross-sectional assessment.
•3. Aged 18 - 75 years, inclusive, either sex
•4. Clinically stable for the last 3 months with a consistent antipsychotic regimen
•5. Competent and willing to provide written, informed consent

•1. Any medical contraindications to an SSRI antidepressant
•2. Currently receiving antidepressant or clinician wants to treat with an antidepressant
•3. Currently fulfil criteria for major depressive disorder; alcohol/substance hazardous use or dependence in past 3 months
•4. Treated with ECT in the last 8 weeks
•5. Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures

发起方

Imperial College London (UK)