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

This study has been terminated.
Janssen, LP
Information provided by:
Duke University Identifier:
First received: April 12, 2006
Last updated: June 19, 2013
Last verified: May 2010
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
Drug: Antipsychotic/Risperidone Consta
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Duke University:

Estimated Enrollment: 30
Study Start Date: April 2006
Estimated Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

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

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
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Please refer to this study by its identifier: NCT00314613

United States, North Carolina
John Umstead Hospital
Butner, North Carolina, United States, 27509
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Janssen, LP
Principal Investigator: William H Wilson, PhD Duke University
Principal Investigator: Joseph P McEvoy, MD Duke University
  More Information Identifier: NCT00314613     History of Changes
Other Study ID Numbers: 7858  RIS-NAP-4007 
Study First Received: April 12, 2006
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Schizophreniform; Schizophrenia; Schizoaffective Disorders

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on May 04, 2016