Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal

This study is currently recruiting participants.

Verified by Duke University, April 2006

Sponsors and Collaborators:	Duke University Janssen, LP
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00314613

Purpose

Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.

Condition	Intervention	Phase
Schizophrenia	Drug: Antipsychotic/Risperidone Consta	Phase IV

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal

Further study details as provided by Duke University:

Estimated Enrollment:	30
Study Start Date:	April 2006

Detailed Description:

First episode patients have a greater potential for therapeutic response than multi-episode patients, and many of them also havea great desire to rejoin the workforce. Unfortunately, first episode patients become non-compliant or intermittently compliant with prescribed antipsychotic treatment at least as frequently as multi-episode patients. We believe that assured treatment with Risperal CONTSTA will provide first episode patients wiwth their best opporutnity for continued improvement in cognitive function beyond 3 months of treatment and that improvements in cognitive function will be associated with a greater likelihood of employment, real-world outcomes, such as independent living, as well as measures of brain function.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female between 18-40 years of age
meet DSM-IV criteria for first-episode schizophreniform, schizophrenia or schizoaffective disorder

Exclusion Criteria:

pregnant & breast-feeding women
patients with known sensitivity to oral Risperdal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314613

Contacts

Contact: William H Wilson, PhD

919-575-7360

wilso066@mc.duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: William H Wilson, PhD
Sub-Investigator: Joseph P McEvoy, MD
John Umstead Hospital	Recruiting
Butner, North Carolina, United States, 27509

Sponsors and Collaborators

Duke University

Janssen, LP

Investigators

Principal Investigator:	William H Wilson, PhD	Duke University
Principal Investigator:	Joseph P McEvoy, MD	Duke University

More Information

Study ID Numbers:	RIS-NAP-4007, 7858
Study First Received:	April 12, 2006
Last Updated:	April 12, 2006
ClinicalTrials.gov Identifier:	NCT00314613
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Schizophreniform; Schizophrenia; Schizoaffective Disorders

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009