Treating Drug-Resistant Childhood Schizophrenia

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

Northwell Health

ClinicalTrials.gov Identifier:

NCT00048828

First received: November 8, 2002

Last updated: July 1, 2013

Last verified: July 2013

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine Olanzapine Olanzapine pamoate

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

U.S. FDA Resources

Further study details as provided by Northwell Health:

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 (Child, Adult)
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

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, see Learn About Clinical Studies.

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

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 DSIR 84-CTM
Study First Received:	November 8, 2002
Last Updated:	July 1, 2013
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2016

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