The purpose of this study is to see if the newest class of antipsychotic medications can improve the course of patients with first-episode schizophrenia.

Official Title

Preventing Morbidity in First-Episode Schizophrenia

Conditions

– Schizophrenia

Study Type

Interventional

Study Design

Treatment, Randomized

Further Details

Schizophrenia patients generally respond very well to their first round of treatment with antipsychotic medications. However, relapses are common, and the condition can worsen over time. The newest class of antipsychotic medications may be able to prevent this, if begun during the first episode of schizophrenia. Patients will be assigned randomly (like tossing a coin) to 3 years of treatment with 1 of 2 antipsychotic medications: olanzapine or risperidone. Response to medication will be monitored, including symptoms, memory and attention, and any side effects. The effects of long-term treatment will be measured, including any relapses. An individual may be eligible for this study if he/she is 16 to 40 years old and is having his/her first episode of 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.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 16 Years – 40 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria:Patients must have: First episode schizophrenia, schizophreniform disorder or schizoaffective disorderExclusion Criteria:Excluded: Prior treatment with antipsychotic medications.

Total Enrolment

Contact Details

[1] Delbert Robinson, MD, Principal Investigator, The Zucker Hillside Hospital

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