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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00299715 |
Purpose
The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone extended release on global functioning, and the relationship between blood levels and the effectiveness and safety of paliperidone.
| Condition | Intervention | Phase |
|---|---|---|
|
Mood Disorders Bipolar Disorder |
Drug: Paliperidone extended-release |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in the Treatment of Subjects With Acute Manic and Mixed Episodes Associated With Bipolar I Disorder |
| Estimated Enrollment: | 464 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR010834 |
| Study First Received: | March 3, 2006 |
| Last Updated: | June 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00299715 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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mania manic-depressive mixed-state paliperidone bipolar disorder |
paliperidone ER. manic disorder Affective psychosis manic state psychosis |
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Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents |
Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |