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

History of Changes

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:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

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

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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:

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

ClinicalTrials.gov processed this record on March 03, 2015

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