Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2001-10-31
2006-06-30
Brief Summary
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Detailed Description
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Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Olanzapine
Participants will receive olanzapine for 12 weeks.
2
Clozapine
Participants will receive 12 weeks of clozapine.
Interventions
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Olanzapine
Participants will receive olanzapine for 12 weeks.
Clozapine
Participants will receive 12 weeks of clozapine.
Eligibility Criteria
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Inclusion Criteria
* Willingness to use an acceptable form of birth control, if applicable
Exclusion Criteria
* IQ less than 70
* DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
* Failure of an adequate trial of olanzapine or clozapine
10 Years
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Northwell Health
OTHER
Responsible Party
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The Zucker Hillside Hospital
Principal Investigators
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Christoph U. Correll, MD
Role: PRINCIPAL_INVESTIGATOR
The Zucker Hillside Hospital
Locations
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Sagamore Children's Psychiatric Center
Dix Hills, New York, United States
Long Island Jewish Medical Center
Glen Oaks, New York, United States
Bronx Children's Psychiatric Center
The Bronx, New York, United States
Countries
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Other Identifiers
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