title: Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol.
abstract: In a randomized, double-blind trial, patients with acute bipolar mania received 1-6 mg/day of risperidone, 2-12 mg/day of haloperidol, or placebo for 3 weeks, followed by double-blind risperidone or haloperidol for 9 weeks. Of 438 patients, 154 were randomized to risperidone, 144 to haloperidol, and 140 to placebo. The mean+/-S.D. modal doses were 4.2+/-1.7 mg/day of risperidone and 8.0+/-3.6 mg/day of haloperidol during the initial 3-week phase and 4.1+/-1.8 and 7.4+/-3.7 mg/day during the 12-week period. At week 3, mean Young Mania Rating Scale (YMRS) score reductions from baseline were significantly greater in patients receiving risperidone than placebo (p<0.001). Differences between risperidone and haloperidol on this efficacy measure were not significant. Further reductions in YMRS scores were seen in patients receiving risperidone or haloperidol during the subsequent 9 weeks. No unexpected adverse events were reported. Extrapyramidal disorder and hyperkinesias, the most commonly reported adverse events with antipsychotic use, occurred less frequently with risperidone than haloperidol. We conclude that risperidone monotherapy was an effective and well-tolerated treatment for bipolar mania and that efficacy was maintained over the long term.
authors.affiliation: National Mental Health Research Center, Moscow, Russia.
authors.forename: Anatoly B
authors.initials: AB
authors.lastname: Smulevich
authors.forename: Sumant
authors.initials: S
authors.lastname: Khanna
authors.forename: Mariëlle
authors.initials: M
authors.lastname: Eerdekens
authors.forename: Keith
authors.initials: K
authors.lastname: Karcher
authors.forename: Michelle
authors.initials: M
authors.lastname: Kramer
authors.forename: Fred
authors.initials: F
authors.lastname: Grossman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001714:Bipolar Disorder / Q000188:drug therapy*; D018492:Dopamine Antagonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage*; D006801:Humans; D008140:Lorazepam / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage*; D012702:Serotonin Antagonists / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018492:Dopamine Antagonists; D010919:Placebos; D012702:Serotonin Antagonists; D006220:Haloperidol; D018967:Risperidone; D008140:Lorazepam