Treating Drug-Resistant Childhood Schizophrenia

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ClinicalTrials.gov Identifier: NCT00048828

Recruitment Status : Completed

First Posted : November 13, 2002

Last Update Posted : July 2, 2013

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

Northwell Health

Study Description

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.

Study Design


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

Genetics Home Reference related topics: Schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine Olanzapine

Genetic and Rare Diseases Information Center resources: Childhood-Onset Schizophrenia

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Northwell Health

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Christoph U. Correll, MD	The Zucker Hillside Hospital

More Information


Responsible Party:	Christoph U. Correll, MD, The Zucker Hillside Hospital
ClinicalTrials.gov Identifier:	NCT00048828 History of Changes
Other Study ID Numbers:	R01MH060229 ( U.S. NIH Grant/Contract ) R01MH060229 ( U.S. NIH Grant/Contract ) DSIR 84-CTM
First Posted:	November 13, 2002 Key Record Dates
Last Update Posted:	July 2, 2013
Last Verified:	July 2013

Additional relevant MeSH terms:


Schizophrenia Schizophrenia, Childhood Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Neurodevelopmental Disorders Olanzapine Clozapine Antiemetics 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

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