Treatment for First-Episode Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00000374|
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : January 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Olanzapine Drug: Risperidone||Phase 4|
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.
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Morbidity in First-Episode Schizophrenia|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
- Drug: Olanzapine
The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects.
- Drug: Risperidone
The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects.
- Treatment response [ Time Frame: 8 consecutive weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000374
|United States, New York|
|Bronx-Lebanon Hospital Center|
|Bronx, New York, United States, 10456|
|Glen Oaks, New York, United States, 11004|
|Principal Investigator:||Delbert Robinson, MD||The Zucker Hillside Hospital|