Treatment for First-Episode Schizophrenia - Full Text View

Sponsor:	North Shore Long Island Jewish Health System
Collaborators:	National Institute of Mental Health (NIMH) The Zucker Hillside Hospital
Information provided by (Responsible Party):	Delbert Robinson, 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Preventing Morbidity in First-Episode Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Olanzapine

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Treatment response [ Time Frame: 8 consecutive weeks ] [ Designated as safety issue: No ]

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:

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.

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

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
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10456
Hillside Hospital
Glen Oaks, New York, United States, 11004

Sponsors and Collaborators

North Shore Long Island Jewish Health System

National Institute of Mental Health (NIMH)

The Zucker Hillside Hospital

Investigators

Principal Investigator:

Delbert Robinson, MD

The Zucker Hillside Hospital

More Information

No publications provided

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:	R01 MH060004-01, R01MH060004-01, DSIR 83-ATAP
Study First Received:	November 2, 1999
Last Updated:	January 12, 2012
Health Authority:	United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:

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 and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012