Bipolar Disorder Clinical Trial
Official title:
The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder
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.
Status | Completed |
Enrollment | 291 |
Est. completion date | December 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Meets DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed - hospitalized voluntarily at study initiation for treatment of manic episode - history (prior to study initiation) of at least one documented manic or mixed episode that required treatment - total score >=20 on the Young Mania Rating Scale (YMRS) at start of the study Exclusion Criteria: - Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling - borderline or antisocial personality disorder - history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation - seizure disorder - females who are pregnant or nursing, or those lacking adequate contraception. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Young Mania Rating Scale (YMRS) total score from baseline to end of treatment. | |||
Secondary | Change from baseline to end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; incidence of adverse events throughout study. |
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