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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00048828 |
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 |
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Schizophrenia |
Drug: Olanzapine Drug: Clozapine |
Phase IV |
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.
Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | R01 MH60229, DSIR 84-CTM |
Study First Received: | November 8, 2002 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00048828 |
Health Authority: | United States: Federal Government |
Developmental Disabilities Child Development Disorders, Pervasive Schizophrenia Mental Disorders Clozapine Mental Disorders Diagnosed in Childhood |
Olanzapine Psychotic Disorders Childhood-Onset Schizophrenia Serotonin Schizophrenia and Disorders with Psychotic Features Schizophrenia, Childhood |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |