A multi-centre, double-blind, individually randomised, placebo-controlled, parallel arm RCT with 12-week follow-up to establish the clinical and cost effectiveness of amisulpride augmentation of clozapine in treatment-resistant schizophrenia unresponsive to clozapine - Amisulpride augmentation in clozapine-unresponsive schizophrenia
- Conditions
- Schizophrenia that has proved unresponsive to standard treatment and a subsequent trial of clozapine
- Registration Number
- EUCTR2010-018963-40-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
People aged 18-65 years with a schizophrenic illness that has been unresponsive, at a criterion level of persistent symptom severity (as used by Honer et al 2006), to an adequate trial of clozapine monotherapy in terms of dosage, duration and adherence. Patients must meet the following criteria to be eligible for enrolment: 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 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 • 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. • A Clinical Global Impressions (CGI: Guy 1976) score of 4 or greater (range of possible scores, 1=not mentally ill to 7=extremely ill) • 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
4.2 Exclusion criteria 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. 6. Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method