Treating Drug-Resistant Childhood Schizophrenia
- Registration Number
- NCT00048828
- Lead Sponsor
- Northwell Health
- Brief Summary
This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
- Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
- IQ less than 70
- DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
- Failure of an adequate trial of olanzapine or clozapine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Clozapine - 1 Olanzapine -
- Primary Outcome Measures
Name Time Method Psychotic, manic, aggressive, and depressive symptoms Measured over 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Sagamore Children's Psychiatric Center
🇺🇸Dix Hills, New York, United States
Bronx Children's Psychiatric Center
🇺🇸Bronx, New York, United States
Long Island Jewish Medical Center
🇺🇸Glen Oaks, New York, United States