3. Suggested design of study.
Methods | Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: blinded and independent raters. Duration: at least 52 weeks. |
Participants | Diagnosis: schizophrenia (according to a diagnostic criteria). N = 300.* Age: adults. Sex: both. |
Interventions | 1. Haloperidol. N = 150. 2. Other first‐generation antipsychotic. N = 150. |
Outcomes | Global state: clinically important response to treatment, average score/change of the global state. General: time to all‐cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), carer/other, compliance with treatment, healthy days. Mental state: general measurement and specific domains (depressive symptoms, positive symptoms, negative symptoms) Leaving the study early (‘drop‐out’) due to any reason, due to inefficacy of treatment, and due to adverse events. Adverse events: any serious adverse event recorded. Service use: number of hospitalisation, days in hospital. Quality of life. Social functioning: return to everyday living for 80% of time.* Economic outcomes. Pharmacological interactions. |
Notes | * Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty. |
CGI = Clinical Global Impression.