Treating Drug-Resistant Childhood Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olanzapine
Clozapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Bronx Children's Psychiatric Center
- Sagamore Children's Psychiatric Center
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Psychotic, manic, aggressive, and depressive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00048828
First Posted
November 8, 2002
Last Updated
July 1, 2013
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00048828
Brief Title
Treating Drug-Resistant Childhood Schizophrenia
Official Title
Treating Refractory Childhood Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Participants will receive olanzapine for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Clozapine
Intervention Description
Participants will receive 12 weeks of clozapine.
Primary Outcome Measure Information:
Title
Psychotic, manic, aggressive, and depressive symptoms
Time Frame
Measured over 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph U. Correll, MD
Organizational Affiliation
The Zucker Hillside Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx Children's Psychiatric Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Sagamore Children's Psychiatric Center
City
Dix Hills
State/Province
New York
ZIP/Postal Code
11746
Country
United States
Facility Name
Long Island Jewish Medical Center
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
12. IPD Sharing Statement
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Treating Drug-Resistant Childhood Schizophrenia
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