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| Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00076115 |
Purpose
A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.
| Condition | Intervention | Phase |
|
Bipolar Disorder |
Drug: Risperidone |
Phase III |
| MedlinePlus related topics: | Bipolar Disorder |
| Drug Information available for: | Risperidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder |
| Estimated Enrollment: | 162 |
| Study Start Date: | December 2003 |
| Study Completion Date: | December 2005 |
Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study.
Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.
Eligibility
| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Study to Determine the Effectivness of Risperidone in Bipolar Disorder in Children and Adolescents 
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| Study ID Numbers: | CR003631 |
| First Received: | January 14, 2004 |
| Last Updated: | March 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00076115 |
| Health Authority: | United States: Food and Drug Administration |
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