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| Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) The Zucker Hillside Hospital |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000374 |
Purpose
This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Olanzapine Drug: Risperidone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Preventing Morbidity in First-Episode Schizophrenia |
| Study Start Date: | September 1998 |
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
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Hillside Hospital | |
| Glen Oaks, New York, United States, 11004 | |
| Bronx-Lebanon Hospital Center | |
| Bronx, New York, United States, 10456 | |
| Principal Investigator: | Delbert Robinson, MD | The Zucker Hillside Hospital |
More Information
| Responsible Party: | The Zucker Hillside Hospital ( Delbert Robinson, MD / Principal Investigator ) |
| Study ID Numbers: | R01 MH060004-01, DSIR 83-ATAP |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00000374 History of Changes |
| Health Authority: | United States: Federal Government |
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Adolescence Adult Antipsychotic Agents Female Human Male olanzapine |
Risperidone Schizophrenia Antipsychotic Agents -- *therapeutic use olanzapine -- *therapeutic use Risperidone -- *therapeutic use Schizophrenia -- *drug therapy |
|
Neurotransmitter Agents Tranquilizing Agents Olanzapine Risperidone Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors |
Serotonin Schizophrenia Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
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Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Olanzapine Antiemetics Schizophrenia Serotonin Antagonists Mental Disorders Therapeutic Uses Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents |
Risperidone Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |