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. 2017 Apr 7;2017(4):CD011810. doi: 10.1002/14651858.CD011810.pub2

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