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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treating Refractory Childhood Schizophrenia |
| Enrollment: | 41 |
| Study Start Date: | October 2001 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Olanzapine
Participants will receive olanzapine for 12 weeks.
|
| Active Comparator: 2 |
Drug: Clozapine
Participants will receive 12 weeks of clozapine.
|
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| United States, New York | |
| Bronx Children's Psychiatric Center | |
| Bronx, New York, United States, 10461 | |
| Sagamore Children's Psychiatric Center | |
| Dix Hills, New York, United States, 11746 | |
| Long Island Jewish Medical Center | |
| Glen Oaks, New York, United States, 11004 | |
| Principal Investigator: | Christoph U. Correll, MD | The Zucker Hillside Hospital |
More Information
| Responsible Party: | Christoph U. Correll, MD, The Zucker Hillside Hospital |
| ClinicalTrials.gov Identifier: | NCT00048828 History of Changes |
| Other Study ID Numbers: | R01 MH060229, DSIR 84-CTM |
| Study First Received: | November 8, 2002 |
| Last Updated: | April 30, 2009 |
| Health Authority: | United States: Federal Government |
|
Schizophrenia Schizophrenia, Childhood Schizophrenia and Disorders with Psychotic Features Mental Disorders Mental Disorders Diagnosed in Childhood Clozapine Olanzapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
