Risperidone in combination with mood stabilizers for acute mania: a multicentre, open study

Int Clin Psychopharmacol. 2004 Sep;19(5):299-303. doi: 10.1097/01.yic.0000138821.85744.20.


The primary aims of this study were (i) a replication of the effectiveness and tolerability of risperidone in the treatment of patients with acute mania in a very large cohort in a naturalistic treatment setting and (ii) to extend the data on the effect and tolerability of risperidone in the treatment of patients with acute mania to an Asian population. A total of 909 patients fulfilling DSM-IV criteria of bipolar disorder (current manic and hypomanic episode) entered this large, open, multicentre study. The Young Mania Rating Scale (YMRS), Clinical Global Impression (CGI) and Simpson-Angus Rating Scale (SARS) were measured at baseline and weeks 1, 3 and 6, for the assessment of effectiveness and extrapyramidal symptoms. This study showed a statistically significant reduction of scores on the YMRS and CGI-severity (mean change=-23.5+/-11.8, P<0.0001; mean change=-2.7+/-1.5, P<0.0001, respectively) from baseline to endpoint (week 6). The number of patients with a 50% reduction or more in the YMRS and CGI-severity scores was 693 (77.8%) and 630 (70.7%) at endpoint, respectively. There were no statistically significant increments of scores on SARS. Risperidone was generally well tolerated. The present larger open study indicates that risperidone add-on therapy is effective and tolerable in treatment of bipolar disorder, replicating results in various controlled and uncontrolled studies from Western countries.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Asia / ethnology
  • Basal Ganglia Diseases / chemically induced
  • Bipolar Disorder / drug therapy*
  • Bipolar Disorder / ethnology
  • Bipolar Disorder / psychology
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Reproducibility of Results
  • Risperidone / administration & dosage
  • Risperidone / adverse effects
  • Risperidone / therapeutic use*
  • Severity of Illness Index
  • Treatment Outcome


  • Antipsychotic Agents
  • Risperidone