Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Participants will receive additional treatment with either clozapine or identical placebo, randomly assigned. Treatment with clozapine will be initiated at 20mg/day for the first 4 weeks (or one place
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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): 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a criterion response threshold of a 20% reduction in total Positive and Negative Syndrome Scale (PANSS) score. All outcomes will be assessed at baseline and 3, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PANSS negative symptom subscale score 2. Calgary Depression Rating Scale for Schizophrenia 3. Social and Occupational Functioning Assessment Scale 4. Service Engagement Scale 5. Antipsychotic side effect measures 6. Euroqol EQ-5D health status questionnaire 7. Resource use data questionnaire All outcomes will be assessed at baseline and 3, 9 and 12 months. | — |
Countries
United Kingdom
Outcome results
None listed