Treating Drug-Resistant Childhood Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00048828|
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Olanzapine Drug: Clozapine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treating Refractory Childhood Schizophrenia|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
U.S. FDA Resources
|Active Comparator: 1||
Participants will receive olanzapine for 12 weeks.
|Active Comparator: 2||
Participants will receive 12 weeks of clozapine.
- Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048828
|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|