Clinical Trial: Treating Drug-Resistant Childhood Schizophrenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treating Refractory Childhood 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 Summary:

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.

Sponsor: Northwell Health

Current Primary Outcome: Psychotic, manic, aggressive, and depressive symptoms [ Time Frame: Measured over 12 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwell Health

Dates:
Date Received: November 8, 2002
Date Started: October 2001
Date Completion:
Last Updated: July 1, 2013
Last Verified: July 2013