ISRCTN99672552已完成未知
Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial
Greater Manchester West Mental Health NHS Foundation Trust (UK)0 个研究点目标入组 487 人开始时间: 2012年11月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 487
研究概览
简要总结
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27496180 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30806619
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria from 04/12/2012 (trial record updated 07/03/2014):
- •1. A criterion level of persistent symptom severity despite an adequate trial of clozapine in terms of dosage, duration and adherence (as used by Honer et al 2006):
- •1.1. Treatment of clozapine at a stable dose of 400mg or more (unless limited by tolerability) for at least 12 weeks, or if currently augmented with a second antipsychotic that this has been given for at least 12 weeks, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months
- •1.2. Presence of at least one psychotic symptom with severity =4 (for hallucinations/delusions) or =5 (for suspiciousness/grandiosity) on the PANSS in addition to a PANSS total score of at least 58, which is equivalent to a clinical global impression (CGI) of being at least mildly ill 51
- •2. Be in contact with mental health services and have a care coordinator
- •3. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
- •4. Aged at least 16 years old
- •5. Competent and willing to provide written, informed consent.
- •Original inclusion criteria:
- •1. A criterion level of persistent symptom severity despite an adequate trial of clozapine monotherapy in terms of dosage, duration and adherence (as used by Honer et al. 2006): Treatment for at least 24 weeks at a stable dose of 400 mg or more of clozapine a day, unless the size of the dose was limited by side effects, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months.
- •2. Presence of at least one psychotic symptom with severity 4 (for hallucinations/delusions) or 5 (for suspiciousness/grandiosity) on the Positive and Negative Syndrome Scale (PANSS) in addition to a PANSS total score of at least 58, which is equivalent to a Clinical Global Impression (CGI) of being at least mildly ill.
- •3. Be in contact with mental health services and have a care coordinator
- •4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
- •5. Male & female aged at least 16 years old
- •6. Competent and willing to provide written, informed consent
排除标准
- •1. Primary diagnosis of alcohol/substance dependence, where this is clearly the cause of their psychotic symptoms
- •2. Developmental disability
- •3. Non-English speaking
- •4. Current receipt (or within the last 12 months) of structured CBT from a qualified psychological therapist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions)
研究者
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