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Treating Drug-Resistant Childhood Schizophrenia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2005
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00048828
  Purpose

This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Olanzapine
Drug: Clozapine
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine Clozapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Treating Refractory Childhood Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 80
Study Start Date: October 2001
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048828

Contacts
Contact: Sanjiv Kumra, MD 718-470-4161

Locations
United States, New York
Bronx Children's Psychiatric Center Recruiting
Bronx, New York, United States, 10461
Contact: Harvey Kranzler, MD     718-239-3624     bcmdhnk@omh.state.ny.us    
Contact: William Ansorge, PhD     718-239-3600        
Sub-Investigator: Frantz Moise, MD            
Sagamore Children's Psychiatric Center Recruiting
Dix Hills, New York, United States, 11746
Contact: Frantz Moise, MD     631-673-7757        
Contact: James McCarthy, PhD     718.264.4608        
Sub-Investigator: Frantz Moise, MD            
Long Island Jewish Medical Center Recruiting
Glen Oaks, New York, United States, 11004
Contact: Sanjiv Kumra, MD     718-470-4161        
Contact: Vivian Kafantaris     718-470-8141        
Sub-Investigator: Sanjiv Kumra, MD            
Principal Investigator: John M Kane, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: John M Kane, M.D. The Zucker Hillside Hospital
  More Information

Study ID Numbers: R01 MH60229, DSIR 84-CTM
Study First Received: November 8, 2002
Last Updated: November 17, 2005
ClinicalTrials.gov Identifier: NCT00048828  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Developmental Disabilities
Child Development Disorders, Pervasive
Schizophrenia
Mental Disorders
Clozapine
Mental Disorders Diagnosed in Childhood
Olanzapine
Psychotic Disorders
Childhood-Onset Schizophrenia
Serotonin
Schizophrenia and Disorders with Psychotic Features
Schizophrenia, Childhood

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 30, 2009