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Clinical Trials/NCT00182013
NCT00182013
Completed
Phase 4

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

Massachusetts General Hospital0 sites106 target enrollmentJune 2001
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ConditionsBipolar Spectrum Disorder
DrugsRisperidoneOlanzapineQuetiapine

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Bipolar Spectrum Disorder
Sponsor
Massachusetts General Hospital
Enrollment
106
Primary Endpoint
Young Mania Rating Scale
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Registry
clinicaltrials.gov
Start Date
June 2001
End Date
February 2004
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Biederman, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • •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
  • •Patient must be able to participate in mandatory blood draws.
  • •Patient must be able to swallow pills.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Young Mania Rating Scale

Time Frame: baseline to 8 weeks

Improvement defined as score reduction of 30% or greater.

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