Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
125 participants
INTERVENTIONAL
1998-09-30
2007-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
40 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
The Zucker Hillside Hospital
OTHER
Northwell Health
OTHER
Responsible Party
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Delbert Robinson
Delbert Robinson, MD/Prinicipal Investigator
Principal Investigators
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Delbert Robinson, MD
Role: PRINCIPAL_INVESTIGATOR
The Zucker Hillside Hospital
Locations
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Hillside Hospital
Glen Oaks, New York, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, United States
Countries
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References
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Gallego JA, Robinson DG, Sevy SM, Napolitano B, McCormack J, Lesser ML, Kane JM. Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months? J Clin Psychiatry. 2011 Dec;72(12):1691-6. doi: 10.4088/JCP.10m06349. Epub 2011 Sep 6.
Other Identifiers
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