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Treatment for First-Episode Schizophrenia
This study has been completed.
Study NCT00000374   Information provided by National Institute of Mental Health (NIMH)
First Received: November 2, 1999   Last Updated: February 19, 2009   History of Changes

November 2, 1999
February 19, 2009
September 1998
 
 
 
Complete list of historical versions of study NCT00000374 on ClinicalTrials.gov Archive Site
 
 
 
Treatment for First-Episode Schizophrenia
Preventing Morbidity in First-Episode Schizophrenia

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

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

Phase IV
Interventional
Treatment, Randomized
Schizophrenia
  • Drug: Olanzapine
  • Drug: Risperidone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Inclusion Criteria:

  • First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria:

  • Prior treatment with antipsychotic medications.
Both
16 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000374
Delbert Robinson, MD / Principal Investigator, The Zucker Hillside Hospital
R01 MH060004-01, DSIR 83-ATAP
National Institute of Mental Health (NIMH)
The Zucker Hillside Hospital
Principal Investigator: Delbert Robinson, MD The Zucker Hillside Hospital
National Institute of Mental Health (NIMH)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP