3. Suggestions for design of future study.
Methods | Allocation: randomised, with sequence generation and concealment of allocation clearly described Blindness: double, tested Duration: 12 months beyond end of intervention at least Raters: independent |
Participants | Diagnosis: people with schizophrenia ‐ however diagnosed* Age: any Sex: both History: any N = 300** |
Interventions | 1. Clotiapine: ˜100 mg/day. N = 150 2. Chlorpromazine: ˜400 mg/day. N = 150 |
Outcomes | Global state ‐ relapse, clinically important change Mental state ‐ general ‐ clinically important change in mental state, average change in negative symptoms Adverse effects ‐ incidence of serious adverse events/effects, clinically important extrapyramidal symptoms Leaving the study early ‐ for any reason Cost of care Service outcomes: admitted, number of admissions, length of hospitalisation, discharge, contacts with psychiatric services Compliance with drugs Economic evaluations: cost‐effectiveness, cost‐benefit |
Notes | *This could be diagnosed by clinical decision. If funds were permitting all participants could be screened using operational criteria, otherwise a random sample should suffice. **Size of study with sufficient power to highlight about a 10% difference between groups for primary outcome |