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. Identifier: NCT00048828
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : July 2, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Northwell Health

November 8, 2002
November 13, 2002
July 2, 2013
October 2001
June 2006   (Final data collection date for primary outcome measure)
Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]
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Complete list of historical versions of study NCT00048828 on Archive Site
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Treating Drug-Resistant Childhood Schizophrenia
Treating Refractory 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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Olanzapine
    Participants will receive olanzapine for 12 weeks.
  • Drug: Clozapine
    Participants will receive 12 weeks of clozapine.
  • Active Comparator: 1
    Intervention: Drug: Olanzapine
  • Active Comparator: 2
    Intervention: Drug: Clozapine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2006
June 2006   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
  • Willingness to use an acceptable form of birth control, if applicable

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
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH060229( U.S. NIH Grant/Contract )
R01MH060229 ( U.S. NIH Grant/Contract )
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Christoph U. Correll, MD, The Zucker Hillside Hospital
Northwell Health
National Institute of Mental Health (NIMH)
Principal Investigator: Christoph U. Correll, MD The Zucker Hillside Hospital
Northwell Health
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP