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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314613
First Posted: April 14, 2006
Last Update Posted: June 20, 2013
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.
Collaborator:
Janssen, LP
Information provided by:
Duke University
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00314613


Locations
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
Investigators
Principal Investigator: William H Wilson, PhD Duke University
Principal Investigator: Joseph P McEvoy, MD Duke University
  More Information

ClinicalTrials.gov Identifier: NCT00314613     History of Changes
Other Study ID Numbers: 7858
RIS-NAP-4007
First Submitted: April 12, 2006
First Posted: April 14, 2006
Last Update Posted: June 20, 2013
Last Verified: May 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
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