Status:
COMPLETED
Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bipolar Spectrum Disorder
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 wee...
Eligibility Criteria
Inclusion
- Males and females age 6 to 18 years of age
- Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
- Patients must have an initial score on the Y-MRS total score of at least 15.
- Patient must be able to participate in mandatory blood draws.
- Patient must be able to swallow pills.
Exclusion
- Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00182013
Start Date
June 1 2001
Last Update
June 13 2013
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