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

This study has been terminated.
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00314613
First received: April 12, 2006
Last updated: June 19, 2013
Last verified: May 2010

April 12, 2006
June 19, 2013
April 2006
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00314613 on ClinicalTrials.gov Archive Site
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Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Antipsychotic/Risperidone Consta
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
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December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00314613
7858, 7858, RIS-NAP-4007
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Duke University
Janssen, LP
Principal Investigator: William H Wilson, PhD Duke University
Principal Investigator: Joseph P McEvoy, MD Duke University
Duke University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP