Status:
COMPLETED
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
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 yea...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00076115
Start Date
December 1 2003
End Date
December 1 2005
Last Update
June 8 2011
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