The Community Care for People with Schizophrenia in India (COPSI) Trial: a multi-centre, parallel group randomised controlled trial for evaluating the clinical effectiveness and cost-effectiveness of a collaborative community-based intervention (CCBI) for improving symptoms and social function in people with schizophrenia compared to facility-based care (FBC) in a low income country setting (India), using a parallel group randomised controlled trial design

Kings College London (UK)0 个研究点目标入组 327 人开始时间: 2009年10月12日最近更新: 2016年10月17日

适应症

试验速览

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•Since this is an effectiveness trial, we propose to have broad inclusion criteria that can be generalised to routine, real life settings. Therefore, for inclusion in the trial participants must:
•1. Be between the ages of 18 - 60 years, either sex
•2. Meet International Classification of Disease, 10th revision, Diagnostic Criteria for Research (ICD-10 DCR) criteria for schizophrenia
•3. Have been ill for at least 12 months
•4. Be currently having at least an moderate overall severity of the illness based on the Clinical Global Impression-Schizophrenia (CGI-S) scale rating
•Two pathways for recruitment are anticipated: people from within the existing caseloads at each of the sites who have ongoing positive symptoms or those who present with a relapse of symptoms; and people who have presented for care for the first time and meet all inclusion criteria irrespective of their treatment status.

•1. The presence of a medical illness needing immediate hospitalisation
•2. Participant is unlikely to reside in the identified CBI area for the duration of the study

发起方

Kings College London (UK)