RIS‐INT‐69 2004.

Methods	Double‐blind randomised controlled trial. Duration ‐ 3 weeks. Multicentre trial. At least 3 days washout period from psychotropics (except benzodiazepines) and substances incuding alcohol. Multicentre conducted in USA.
Participants	227 patients screened of whom 262 were randomised. Mean age 38.1 (se 1.0) risperidone group and 39.5 (se 1.1) placebo group. Inclusion criteria: Age 18 or over, informed consent, DSM‐IV criteria for bipolar I disorder most recent episode manic, voluntary hospitalisation with primary diagnosis of mania, history of at least one prior manic or mixed episode, baseline YMRS of 20 or greater and baseline MADRS 20 or less. Exclusion criteria: DSM‐IV criteria for mixed episode, schizoaffective disorder, or borderline or antisocial personality disorder, antidepressant ‐induced mania, 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 clozapine or ECT within 4 weeks of screening, history of poor response to antimanic or antipsychotic monotherapy or hypersensitivity /allergy to risperidone or similar drugs.
Interventions	Risperidone versus placebo as monotherapy. Risperidone starting dose 3mg/day altered over 3 days to 1‐6mg/day, mean modal dose 4.1 (se 0.1) mg/day. Rescue medication: lorazepam up to day 10 (but not in the 8‐hour period before behavioural assessment) and antiparkinsonian medication.
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	Randomisation using IVRS.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate