- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048828
Treating Drug-Resistant Childhood Schizophrenia
Treating Refractory Childhood Schizophrenia
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Bronx Children's Psychiatric Center
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Dix Hills, New York, United States, 11746
- Sagamore Children's Psychiatric Center
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Glen Oaks, New York, United States, 11004
- Long Island Jewish Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
Participants will receive 12 weeks of clozapine.
|
Active Comparator: 1
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Participants will receive olanzapine for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychotic, manic, aggressive, and depressive symptoms
Time Frame: Measured over 12 weeks
|
Measured over 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christoph U. Correll, MD, The Zucker Hillside Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Neurodevelopmental Disorders
- Schizophrenia
- Schizophrenia, Childhood
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Antagonists
- GABA Agents
- GABA Antagonists
- Olanzapine
- Clozapine
Other Study ID Numbers
- R01MH060229 (U.S. NIH Grant/Contract)
- DSIR 84-CTM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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