Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial.
BACKGROUND
Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania.


OBJECTIVE
To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania.


METHODS
Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76).


RESULTS
Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P<0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups.


CONCLUSIONS
Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.
Yatham
Laksami N
LN
University of British Columbia, Vancouver, Canada. yatham@interchange.ubc.ca
Grossman
Fred
F
Augustyns
Ilse
I
Vieta
Eduard
E
Ravindran
Arun
A
D000328:Adult; D000368:Aged; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001714:Bipolar Disorder / Q000188:drug therapy*; D010054:Brief Psychiatric Rating Scale; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000627:therapeutic use; D008140:Lorazepam / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D016312:Treatment Refusal; D014635:Valproic Acid / Q000627:therapeutic use
D018692:Antimanic Agents; D014150:Antipsychotic Agents; D018020:Lithium Compounds; D014635:Valproic Acid; D018967:Risperidone; D008140:Lorazepam