Treating Drug-Resistant Childhood Schizophrenia

Schizophrenia Clinical Trial

Official title:

Treating Refractory Childhood Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048828
• Other study ID #: R01MH060229
• Secondary ID: R01MH060229DSIR
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2002
• Last updated: July 1, 2013
• Start date: October 2001
• Est. completion date: June 2006

Study information

• Verified date: July 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia, Childhood

Intervention

Drug:
• Olanzapine
Participants will receive olanzapine for 12 weeks.
• Clozapine
Participants will receive 12 weeks of clozapine.

Locations

Country	Name	City	State
United States	Bronx Children's Psychiatric Center	Bronx	New York
United States	Sagamore Children's Psychiatric Center	Dix Hills	New York
United States	Long Island Jewish Medical Center	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotic, manic, aggressive, and depressive symptoms		Measured over 12 weeks	Yes