Table 1. Suggested design of future study.
Methods | Allocation: randomised - clearly described generation of sequence and concealment of allocation. Blindness: double - described and tested. Duration: 6 months minimum. |
Participants | Diagnosis: schizophrenia (operational criteria). N=2700.* Age: any. Sex: both. History: any. |
Interventions |
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Outcomes | Leaving study early (any reason, adverse events, inefficacy). Service outcomes: hospitalised, time in hospital, attending out patient clinics. Global impression: CGI**, relapse. Mental state: PANSS. Adverse events: UKU. Employment, family satisfaction, patient satisfaction. |
power calculation suggested 300/group would allow good chance of showing a 10% difference between groups for primary outcome.
Primary outcome