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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:
ClinicalTrials.gov Identifier:
NCT00209027
First Posted: September 21, 2005
Last Update Posted: December 6, 2013
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.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Erica Duncan, MD, Emory University
  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: None (Open Label)
Official Title: Aripiprazole Effects on Reward Processing in Deficit Syndrome Schizophrenia

Resource links provided by NLM:


Further study details as provided by Erica Duncan, MD, Emory University:

Primary Outcome Measures:
  • 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.


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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Berman KF, Zec RF, Weinberger DR. Physiologic dysfunction of dorsolateral prefrontal cortex in schizophrenia. II. Role of neuroleptic treatment, attention, and mental effort. Arch Gen Psychiatry. 1986 Feb;43(2):126-35.
Büchel C, Holmes AP, Rees G, Friston KJ. Characterizing stimulus-response functions using nonlinear regressors in parametric fMRI experiments. Neuroimage. 1998 Aug;8(2):140-8.
Burris KD, Molski TF, Xu C, Ryan E, Tottori K, Kikuchi T, Yocca FD, Molinoff PB. Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther. 2002 Jul;302(1):381-9.
Childress AR, Mozley PD, McElgin W, Fitzgerald J, Reivich M, O'Brien CP. Limbic activation during cue-induced cocaine craving. Am J Psychiatry. 1999 Jan;156(1):11-8.
Davis KL, Kahn RS, Ko G, Davidson M. Dopamine in schizophrenia: a review and reconceptualization. Am J Psychiatry. 1991 Nov;148(11):1474-86. Review.
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
Garavan H, Pankiewicz J, Bloom A, Cho JK, Sperry L, Ross TJ, Salmeron BJ, Risinger R, Kelley D, Stein EA. Cue-induced cocaine craving: neuroanatomical specificity for drug users and drug stimuli. Am J Psychiatry. 2000 Nov;157(11):1789-98.
Elliott R, Friston KJ, Dolan RJ. Dissociable neural responses in human reward systems. J Neurosci. 2000 Aug 15;20(16):6159-65.
Elliott R, Newman JL, Longe OA, Deakin JF. Differential response patterns in the striatum and orbitofrontal cortex to financial reward in humans: a parametric functional magnetic resonance imaging study. J Neurosci. 2003 Jan 1;23(1):303-7.
Kilts CD, Schweitzer JB, Quinn CK, Gross RE, Faber TL, Muhammad F, Ely TD, Hoffman JM, Drexler KP. Neural activity related to drug craving in cocaine addiction. Arch Gen Psychiatry. 2001 Apr;58(4):334-41.
Koob GF. Drugs of abuse: anatomy, pharmacology and function of reward pathways. Trends Pharmacol Sci. 1992 May;13(5):177-84. Review.
Weinberger DR. Implications of normal brain development for the pathogenesis of schizophrenia. Arch Gen Psychiatry. 1987 Jul;44(7):660-9.
Wexler BE, Gottschalk CH, Fulbright RK, Prohovnik I, Lacadie CM, Rounsaville BJ, Gore JC. Functional magnetic resonance imaging of cocaine craving. Am J Psychiatry. 2001 Jan;158(1):86-95.

Responsible Party: Erica Duncan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209027     History of Changes
Other Study ID Numbers: IRB00024777
570-024 ( Other Identifier: Other )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: April 13, 2012
Results First Posted: June 18, 2012
Last Update Posted: December 6, 2013
Last Verified: November 2013

Keywords provided by Erica Duncan, MD, Emory University:
schizophrenia
reward
fMRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs


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