NCT00209027

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 18, 2012

Completed
Last Updated

December 6, 2013

Status Verified

November 1, 2013

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Results QC Date

April 13, 2012

Last Update Submit

November 13, 2013

Conditions

Schizophrenia

Keywords

schizophreniarewardfMRI

Outcome Measures

Primary Outcomes (1)

  • BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task

    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.

    Baseline and 12 weeks

Study Arms (1)

schizophrenia subjects

EXPERIMENTAL

Patients to be switched from baseline medication to aripiprazole, and fMRI measured at baseline and after med switch.

Other: fMRIDrug: Aripiprazole

Interventions

fMRIOTHER

fMRI scanning during behavioral reward task

schizophrenia subjects
AripiprazoleDRUG

30 mg by mouth once daily

schizophrenia subjects

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • No current or past drug or alcohol problems (dependance or abuse)
  • Not color blind
  • Control Subjects:
  • Male
  • Age 20-50
  • Right handed
  • No current psychiatric problems
  • No current or past drug or alcohol problems
  • Not color blind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Related Publications (13)

  • 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. doi: 10.1001/archpsyc.1986.01800020032005.

    PMID: 2868701BACKGROUND

  • Buchel 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. doi: 10.1006/nimg.1998.0351.

    PMID: 9740757BACKGROUND

  • 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. doi: 10.1124/jpet.102.033175.

    PMID: 12065741BACKGROUND

  • 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. doi: 10.1176/ajp.156.1.11.

    PMID: 9892292BACKGROUND

  • Davis KL, Kahn RS, Ko G, Davidson M. Dopamine in schizophrenia: a review and reconceptualization. Am J Psychiatry. 1991 Nov;148(11):1474-86. doi: 10.1176/ajp.148.11.1474.

    PMID: 1681750BACKGROUND

  • 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

    BACKGROUND

  • 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. doi: 10.1176/appi.ajp.157.11.1789.

    PMID: 11058476BACKGROUND

  • Elliott R, Friston KJ, Dolan RJ. Dissociable neural responses in human reward systems. J Neurosci. 2000 Aug 15;20(16):6159-65. doi: 10.1523/JNEUROSCI.20-16-06159.2000.

    PMID: 10934265BACKGROUND

  • 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. doi: 10.1523/JNEUROSCI.23-01-00303.2003.

    PMID: 12514228BACKGROUND

  • 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. doi: 10.1001/archpsyc.58.4.334.

    PMID: 11296093BACKGROUND

  • Koob GF. Drugs of abuse: anatomy, pharmacology and function of reward pathways. Trends Pharmacol Sci. 1992 May;13(5):177-84. doi: 10.1016/0165-6147(92)90060-j.

    PMID: 1604710BACKGROUND

  • Weinberger DR. Implications of normal brain development for the pathogenesis of schizophrenia. Arch Gen Psychiatry. 1987 Jul;44(7):660-9. doi: 10.1001/archpsyc.1987.01800190080012.

    PMID: 3606332BACKGROUND

  • 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. doi: 10.1176/appi.ajp.158.1.86.

    PMID: 11136638BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Although the study was planned as a repeated measures study with fMRI testing at baseline and after 3 months, difficulty with recruitment and technical difficulties with obtaining fMRI data relegated the study to a single baseline timepoint.

Results Point of Contact

Title
Erica Duncan
Organization
Emory University
erica.duncan@va.gov
404-321-6111

Study Officials

  • Erica Duncan, MD

    Emory University/Atlanta VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

December 6, 2013

Results First Posted

June 18, 2012

Record last verified: 2013-11

Locations

US(1)