Amisulpride augmentation in clozapine-unresponsive schizophrenia: a randomised, double-blind, placebo-controlled trial

Imperial College London (UK)0 个研究点目标入组 230 人开始时间: 2010年5月24日最近更新: 2019年10月7日

适应症

试验速览

•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):
•1.1. Treatment for at least 12 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
•1.2. A total score of 80 or greater at baseline on the Positive and Negative Syndrome Scale (PANSS: Kay et al 1987, 1988); the range of possible scores is 30 to 210, with higher scores indicating more severe symptoms.
•1.3. A Clinical Global Impressions (CGI: Guy 1976) score of 4 or greater (range of possible scores, 1=not mentally ill to 7=extremely ill)
•1.4. A Social and Occupational Functioning Assessment Scale (SOFAS: Goldman et al 1992, DSM-IV 1994) score of 40 or less; range of possible scores, 1 to 100, with lower scores indicating impaired functioning.
•2. Age 18-65 years, inclusive
•3. Clinically stable for the last 3 months with a consistent clozapine regimen
•4. Competent and willing to provide written, informed consent

•1. Clinically-significant alcohol/substance use in the previous three months
•2. Developmental disability
•3. Indication for current treatment with clozapine was intolerance/movement disorder
•4. A previous trial of clozapine augmentation with amisulpride
•5. Existing relevant physical health problems: such as cardiovascular disease, previous problems with prolactin, and impaired liver/renal function

发起方

Imperial College London (UK)