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Treating Drug-Resistant Childhood Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00048828
First received: November 8, 2002
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Refractory Childhood Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: October 2001
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Olanzapine
Participants will receive olanzapine for 12 weeks.
Active Comparator: 2 Drug: Clozapine
Participants will receive 12 weeks of clozapine.

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

Locations
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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Christoph U. Correll, MD The Zucker Hillside Hospital
  More Information

No publications provided

Responsible Party: Christoph U. Correll, MD, The Zucker Hillside Hospital
ClinicalTrials.gov Identifier: NCT00048828     History of Changes
Other Study ID Numbers: R01 MH060229, DSIR 84-CTM
Study First Received: November 8, 2002
Last Updated: April 30, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia, Childhood
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Mental Disorders Diagnosed in Childhood
Clozapine
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013