Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00076115
First received: January 14, 2004
Last updated: June 6, 2011
Last verified: April 2010
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- The change in the total YMRS score from baseline at the 3-week endpoint
Secondary Outcome Measures:
- Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.
| Enrollment: | 13 |
| 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 |
Criteria
Inclusion Criteria:
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Aged between 10 and 17 years
- Young Mania Rating Scale score greater than or equal to 20 at screening and baseline
Exclusion Criteria:
- Known or suspected history of substance dependence
- Significant risk for suicidal or violent behavior
- Received electroconvulsive treatment within 4 weeks of baseline
- Received a depot antipsychotic within 2 treatment cycle before baseline
- Is unable to swallow medication taken in the form of tablets
- Has a positive result for a urine drug screen done at baseline
- Known or suspected seizure disorder
- Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
- Known or suspected history of hypersensitivity or intolerance to risperidone
- History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076115
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00076115 History of Changes |
| Other Study ID Numbers: | CR003631 |
| Study First Received: | January 14, 2004 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Bipolar Mania Manic Depressive Manic Depressive |
Bipolar mania risperidone adolescents children |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 16, 2013