Skip to main content
. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

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