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NCT00314613 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00314613
Other study ID # 7858
Secondary ID 7858RIS-NAP-4007
Status Terminated
Phase Phase 4
First received April 12, 2006
Last updated November 29, 2017
Start date April 2006

Study information
Verified date May 2010
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Antipsychotic/Risperidone Consta

Locations
Country Name City State
United States John Umstead Hospital Butner North Carolina
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Janssen, LP

Country where clinical trial is conducted

United States, 

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