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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00048828 |
Purpose
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
| Condition | Intervention | Phase |
|
Schizophrenia |
Drug: Olanzapine Drug: Clozapine |
Phase IV |
| MedlinePlus related topics: | Schizophrenia |
| ChemIDplus related topics: | Olanzapine Clozapine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treating Refractory Childhood Schizophrenia |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2001 |
| Estimated Study Completion Date: | October 2006 |
Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.
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.
Eligibility
| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sanjiv Kumra, MD | 718-470-4161 |
| United States, New York | |||||
| Bronx Children's Psychiatric Center | Recruiting | ||||
| Bronx, New York, United States, 10461 | |||||
| Contact: Harvey Kranzler, MD 718-239-3624 bcmdhnk@omh.state.ny.us | |||||
| Contact: William Ansorge, PhD 718-239-3600 | |||||
| Sub-Investigator: Frantz Moise, MD | |||||
| Sagamore Children's Psychiatric Center | Recruiting | ||||
| Dix Hills, New York, United States, 11746 | |||||
| Contact: Frantz Moise, MD 631-673-7757 | |||||
| Contact: James McCarthy, PhD 718.264.4608 | |||||
| Sub-Investigator: Frantz Moise, MD | |||||
| Long Island Jewish Medical Center | Recruiting | ||||
| Glen Oaks, New York, United States, 11004 | |||||
| Contact: Sanjiv Kumra, MD 718-470-4161 | |||||
| Contact: Vivian Kafantaris 718-470-8141 | |||||
| Sub-Investigator: Sanjiv Kumra, MD | |||||
| Principal Investigator: John M Kane, MD | |||||
| Principal Investigator: | John M Kane, M.D. | The Zucker Hillside Hospital |
More Information
| Study ID Numbers: | R01 MH60229, DSIR 84-CTM |
| First Received: | November 8, 2002 |
| Last Updated: | November 17, 2005 |
| ClinicalTrials.gov Identifier: | NCT00048828 |
| Health Authority: | United States: Federal Government |
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