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Related Studies
Treatment for First-Episode Schizophrenia
This study has been completed.
First Received: November 2, 1999   Last Updated: February 19, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Collaborator: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date: September 1998
Detailed Description:

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
Criteria

Inclusion Criteria:

  • First episode schizophrenia, schizophreniform disorder or schizoaffective disorder

Exclusion Criteria:

  • Prior treatment with antipsychotic medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000374

Locations
United States, New York
Hillside Hospital
Glen Oaks, New York, United States, 11004
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10456
Sponsors and Collaborators
The Zucker Hillside Hospital
Investigators
Principal Investigator: Delbert Robinson, MD The Zucker Hillside Hospital
  More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Adolescence
Adult
Antipsychotic Agents
Female
Human
Male
olanzapine
Risperidone
Schizophrenia
Antipsychotic Agents -- *therapeutic use
olanzapine -- *therapeutic use
Risperidone -- *therapeutic use
Schizophrenia -- *drug therapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 25, 2009