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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00309686 |
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.
Condition | Intervention | Phase |
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Bipolar Disorder Mania Affective Psychosis, Bipolar |
Drug: Paliperidone ER |
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, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder |
Estimated Enrollment: | 296 |
Study Start Date: | April 2006 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR010855 |
Study First Received: | March 31, 2006 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00309686 |
Health Authority: | United States: Food and Drug Administration |
manic disorder bipolar disorder manic state paliperidone ER mania |
adjunctive therapy paliperidone Affective psychosis manic-depressive psychosis |
Schizophrenia Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Risperidone Mood Disorders |
Lithium Carbonate 9-hydroxy-risperidone Psychotic Disorders Valproic Acid Lithium Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |