1. Suggested design of study.
Methods | Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: single, tested. Setting: community rather than hospital. Duration: 12 weeks treatment, and then follow‐up to at least 52 weeks. |
Participants | Diagnosis: schizophrenia (ICD/DSM/CCMD). N = 300.* Age: adults. Sex: both. |
Interventions | 1. Depot risperidone. N = 150. 2. Standard care. N = 150. |
Outcomes | General: time to all‐cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment., healthy days, Mental state: BPRS and PANSS. Global state: CGI (Clinical Global Impression). Quality of life. QOL (Quality of Life Questionnaire). Family burden: FBQ (Family Burden Questionnaire). Social functioning: return to everyday living for 80% of time.* Adverse events: any adverse event recorded. Economic outcomes. |
Notes | * Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty. |
BPRS: Brief Psychiatric Rating Scale CGI: Clinical Global Impression PANSS: Positive and Negative Syndrome Scale