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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Drug: Clozapine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Refractory Childhood Schizophrenia
Study Start Date : October 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: 1 Drug: Olanzapine
Participants will receive olanzapine for 12 weeks.

Active Comparator: 2 Drug: Clozapine
Participants will receive 12 weeks of clozapine.

Primary Outcome Measures :
  1. Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00048828

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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
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
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Principal Investigator: Christoph U. Correll, MD The Zucker Hillside Hospital
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Responsible Party: Christoph U. Correll, MD, The Zucker Hillside Hospital Identifier: NCT00048828    
Other Study ID Numbers: R01MH060229 ( U.S. NIH Grant/Contract )
R01MH060229 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2002    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Schizophrenia, Childhood
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurodevelopmental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
GABA Antagonists
GABA Agents