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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: May 25, 2010
Last verified: May 2010
History of Changes
  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: 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:

Drug Information available for: Risperidone
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00314613     History of Changes
Other Study ID Numbers: RIS-NAP-4007, 7858
Study First Received: April 12, 2006
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013