drugset / Trial / NCT00249236
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in patients with Bipolar I Disorder who suffer from manic or mixed episodes.
Timeline
- Start
- 2001-03
- Primary completion
- —
- Completion
- 2001-12
Outcome
Met primary endpoint
paper Significantly greater improvements were observed with risperidone than with placebo at weeks 1 and 2 and at end-point (total YMRS: P <0.01). PMID 16135859 ↗
Publications
- Results Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. Risperidone in the treatment of acute mania: double-blind, placebo-controlled study. Br J Psychiatry. 2005 Sep;187:229-34. doi: 10.1192/bjp.187.3.229.
- Results Gopal S, Steffens DC, Kramer ML, Olsen MK. Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy. J Clin Psychiatry. 2005 Aug;66(8):1016-20. doi: 10.4088/jcp.v66n0809.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 1 mg | Oral |
| Subject | Risperidone | Other / unclassified | 2 mg | Oral |
| Subject | Risperidone | Other / unclassified | 3 mg | Oral |
| Subject | Risperidone | Other / unclassified | 4 mg | Oral |
| Subject | Risperidone | Other / unclassified | 5 mg | Oral |
| Subject | Risperidone | Other / unclassified | 6 mg | Oral |