Abstract | BACKGROUND: METHOD: Subjects received flexible doses of a mood stabilizer ( lithium or divalproex) plus placebo, risperidone, or haloperidol in a 3-week double-blind study. They could then enter a 10-week open-label study during which they received risperidone combined with a mood stabilizer. RESULTS: Of the 156 patients enrolled in the 3-week study, 85 entered the 10-week open-label extension, of whom 48 completed 10 weeks of treatment. The mean +/- SE doses of risperidone were 3.8 +/- 0.3 mg/day during the 3-week study and 3.1 +/- 0.2 mg/day during the 10-week study. At double-blind endpoint, mean reductions in Young Mania Rating Scale (YMRS) scores were significantly greater in patients receiving risperidone plus mood stabilizer than in those receiving placebo plus mood stabilizer (-14.3 vs. -8.2, p <.001). Further significant (p <.001) reductions were seen during the 10 weeks of treatment with risperidone plus mood stabilizer. Symptom remission (YMRS score <or= 12) was seen in 38 patients (79%) at the end of the 10-week study. Scores on the Brief Psychiatric Rating Scale, Hamilton Rating Scale for Depression, and Clinical Global Impressions scale improved significantly (p <.05) during both the 3-week and 10-week studies. Treatment was well tolerated, and modest weight gain was observed during the 13-week study period. CONCLUSION: The combination of risperidone and a mood stabilizer was efficacious and well tolerated in the continuation treatment of patients initially hospitalized for the management of an acute manic episode.
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Authors | Charles L Bowden, Joyce E Myers, Fred Grossman, Yang Xie |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 65
Issue 5
Pg. 707-14
(May 2004)
ISSN: 0160-6689 [Print] United States |
PMID | 15163260
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticonvulsants
- Antipsychotic Agents
- Valproic Acid
- Lithium
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Topics |
- Adult
- Anticonvulsants
(therapeutic use)
- Antipsychotic Agents
(therapeutic use)
- Bipolar Disorder
(diagnosis, drug therapy, psychology)
- Brief Psychiatric Rating Scale
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Hospitalization
- Humans
- Lithium
(therapeutic use)
- Male
- Psychiatric Status Rating Scales
- Severity of Illness Index
- Treatment Outcome
- Valproic Acid
(therapeutic use)
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