Treating Drug-Resistant Childhood Schizophrenia

Treating Refractory 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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Olanzapine; Drug: Clozapine

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Bronx Children's Psychiatric Center
    • Dix Hills, New York, United States, 11746
      • Sagamore Children's Psychiatric Center
    • Glen Oaks, New York, United States, 11004
      • Long Island Jewish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: Clozapine; Participants will receive 12 weeks of clozapine.
Active Comparator: 1	Drug: Olanzapine; Participants will receive olanzapine for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Christoph U. Correll, MD, The Zucker Hillside Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: November 8, 2002
• First Submitted That Met QC Criteria: November 12, 2002
• First Posted (Estimate): November 13, 2002

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: July 1, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurodevelopmental Disorders; Schizophrenia; Schizophrenia, Childhood; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Olanzapine; Clozapine
• Other Study ID Numbers: R01MH060229 (U.S. NIH Grant/Contract); DSIR 84-CTM