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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antipsychotic/Risperidone Consta
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophreniform; Schizophrenia; Schizoaffective Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Umstead Hospital
  • Duke University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 12, 2006
Last Updated
November 29, 2017
Sponsor
Duke University
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00314613
Brief Title
Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Official Title
Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
Janssen, LP

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophreniform; Schizophrenia; Schizoaffective Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Antipsychotic/Risperidone Consta

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H Wilson, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph P McEvoy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Umstead Hospital
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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