Treating Drug-Resistant Childhood Schizophrenia

Treating Refractory Childhood Schizophrenia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048828

Enrollment

Registered

2002-11-13

Start date

2001-10-31

Completion date

2006-06-30

Last updated

2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGOlanzapine

Participants will receive olanzapine for 12 weeks.

DRUGClozapine

Participants will receive 12 weeks of clozapine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Psychotic, manic, aggressive, and depressive symptoms	Measured over 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026