Treating Drug-Resistant Childhood Schizophrenia
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
|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|
- Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2001|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Participants will receive olanzapine for 12 weeks.
|Active Comparator: 2||
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.
|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|