Treating Drug-Resistant Childhood Schizophrenia

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ); DSIR 84-CTM
First Posted:	November 13, 2002
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