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Clinical Trials/NCT00048828
NCT00048828
Completed
Phase 4

Treating Refractory Childhood Schizophrenia

Northwell Health3 sites in 1 country41 target enrollmentOctober 2001

Overview

Phase
Phase 4
Intervention
Olanzapine
Conditions
Schizophrenia
Sponsor
Northwell Health
Enrollment
41
Locations
3
Primary Endpoint
Psychotic, manic, aggressive, and depressive symptoms
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
June 2006
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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

Arms & Interventions

1

Intervention: Olanzapine

2

Intervention: Clozapine

Outcomes

Primary Outcomes

Psychotic, manic, aggressive, and depressive symptoms

Time Frame: Measured over 12 weeks

Study Sites (3)

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