RIS‐IND‐6 2002.

Methods	Double‐blind randomised controlled trial. Duration ‐ 3 weeks. Washout period. Conducted in India.
Participants	291 randomised participants. Mean age 34.7 (se 1.0) risperidone group and 35.5 (se 1.0) placebo group. Inclusion criteria: Age 18 or over, informed consent, DSM‐IV criteria for bipolar I disorder, voluntary hospitalisation with primary diagnosis of manic or mixed episode, history of at least one prior manic or mixed episode, baseline YMRS of 20 or greater. Exclusion criteria: DSM‐IV criteria for schizoaffective disorder, rapid cycling bipolar disorder, or borderline or antisocial personality disorder, substance dependence within last 3 months, significant risk of suicide or violent behaviour, pregnant or nursing, history of other unstable illness, decrease of 25% or greater in YMRS from screening to baseline, treatment with an antidepressant within 4 weeks of screening.
Interventions	Risperidone versus placebo as monotherapy. Risperidone starting dose 3mg/day altered over 3 days to 1‐6mg/day, mean modal dose 5.6 (se 0.8) mg/day. Rescue medication: lorazepam up to day 10.
Outcomes	Primary efficacy measure ‐ change in mean Young Mania Rating Scale (YMRS) from baseline to endpoint.Other measures ‐ Clinical Global Impression (CGI), Positive and negative syndrome score (PANSS), Montgomery‐Asberg Depression Rating Scale (MADRS) and Global Assessment Scale (GAS).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear