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The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00209027
Recruitment Status : Terminated (difficulty with technical aspect of fMRI, resources to complete the study ran out)
First Posted : September 21, 2005
Results First Posted : June 18, 2012
Last Update Posted : December 6, 2013
Bristol-Myers Squibb
Information provided by (Responsible Party):
Erica Duncan, MD, Emory University

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Other: fMRI Drug: Aripiprazole Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Aripiprazole Effects on Reward Processing in Deficit Syndrome Schizophrenia
Study Start Date : April 2005
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task [ Time Frame: Baseline and 12 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00209027

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

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

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Responsible Party: Erica Duncan, MD, Associate Professor, Emory University Identifier: NCT00209027     History of Changes
Other Study ID Numbers: IRB00024777
570-024 ( Other Identifier: Other )
First Posted: September 21, 2005    Key Record Dates
Results First Posted: June 18, 2012
Last Update Posted: December 6, 2013
Last Verified: November 2013
Keywords provided by Erica Duncan, MD, Emory University:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists