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Treatment for First-Episode Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000374
First Posted: November 3, 1999
Last Update Posted: January 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
The Zucker Hillside Hospital
Information provided by (Responsible Party):
Delbert Robinson, National Institute of Mental Health (NIMH)
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventing Morbidity in First-Episode Schizophrenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Treatment response [ Time Frame: 8 consecutive weeks ]

Enrollment: 125
Study Start Date: September 1998
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10456
Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
The Zucker Hillside Hospital
Investigators
Principal Investigator: Delbert Robinson, MD The Zucker Hillside Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Delbert Robinson, Delbert Robinson, MD/Prinicipal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000374     History of Changes
Other Study ID Numbers: R01MH060004-01 ( U.S. NIH Grant/Contract )
DSIR 83-ATAP
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Delbert Robinson, 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:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Olanzapine
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators