Skip to main content
OpenTrials
Completed

NCT Number: NCT00048828

Treating Drug-Resistant Childhood Schizophrenia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sagamore Children's Psychiatric Center, Dix Hills, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

Participants will receive olanzapine for 12 weeks.

Clozapine

Drug

Participants will receive 12 weeks of clozapine.

Primary outcomes

  1. Psychotic, manic, aggressive, and depressive symptoms

    Time frame: Measured over 12 weeks

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treating Refractory Childhood Schizophrenia

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Nov 13, 2002
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.