The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia

This study has been terminated.
(difficulty with technical aspect of fMRI, resources to complete the study ran out)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Erica Duncan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00209027
First received: September 13, 2005
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The objective of this study is to determine whether subjects with negative symptoms of schizophrenia have abnormal functioning of brain circuits relevant to reward processing, and to determine whether any such abnormalities are normalized by treatment with aripiprazole.


Condition Intervention
Schizophrenia
Other: fMRI
Drug: Aripiprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Aripiprazole Effects on Reward Processing in Deficit Syndrome Schizophrenia

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.


Enrollment: 20
Study Start Date: April 2005
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: schizophrenia subjects
Patients to be switched from baseline medication to aripiprazole, and fMRI measured at baseline and after med switch.
Other: fMRI
fMRI scanning during behavioral reward task
Drug: Aripiprazole
30 mg by mouth once daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Subjects with Schizophrenia:

Inclusion Criteria:

  • Diagnosed with schizophrenia
  • Male
  • Age 20-50
  • Right handed

Exclusion Criteria:

  • No current or past drug or alcohol problems (dependance or abuse)
  • Not color blind

Control Subjects:

Inclusion Criteria:

  • Male
  • Age 20-50
  • Right handed

Exclusion Criteria:

  • No current psychiatric problems
  • No current or past drug or alcohol problems
  • Not color blind
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209027

Locations
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Bristol-Myers Squibb
Investigators
Principal Investigator: Erica Duncan, MD Emory University/Atlanta VA Medical Center
  More Information

Publications:
Friston KJ, Ashburner J, Frith CD, Poline J-B, Heather JD, Frackowiak RSJ (1995) Spatial registration and normalization of images. Hum Brain Mapp 2:1-25

Responsible Party: Erica Duncan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209027     History of Changes
Other Study ID Numbers: IRB00024777, 570-024
Study First Received: September 13, 2005
Results First Received: April 13, 2012
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
schizophrenia
reward
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014