Treatment for First-Episode Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00000374
• Lead Sponsor: Northwell Health

Brief Summary

This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.

Detailed Description

The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.

Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.

First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00320671

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria

• Prior treatment with antipsychotic medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment response	8 consecutive weeks

Trial Locations

Locations (2)

Bronx-Lebanon Hospital Center; 🇺🇸 Bronx, New York, United States

Hillside Hospital; 🇺🇸 Glen Oaks, New York, United States