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Functional Magnetic Resonance Imaging (fMRI) Studies in Pathological Gambling (PG) and Obsessive-Compulsive Disorder (OCD)

This study has been terminated.
(Enrollments closed after former PI Eric Hollander left institution. There are no results.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211822
First Posted: September 21, 2005
Last Update Posted: July 14, 2011
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:
Abbott
Information provided by:
Icahn School of Medicine at Mount Sinai
  Purpose
This study will explore the brain processes associated with inhibition and reward processing in pathological gamblers and people with obsessive compulsive disorder compared to healthy controls.

Condition Intervention
Pathological Gambling Obsessive Compulsive Disorder Procedure: fMRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • fMRI - go-nogo task [ Time Frame: at baseline ]
    a measure of behavioral response inhibition

  • fMRI - monetary incentive delay (MID) task [ Time Frame: at baseline ]
    a measure of neural response to anticipating and receiving monetary rewards


Enrollment: 57
Study Start Date: November 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pathologic Gamblers Procedure: fMRI
fMRI
Obsessive Compulsive Disorder Procedure: fMRI
fMRI
Healthy Controls Procedure: fMRI
fMRI

Detailed Description:
This study will explore the brain processes associated with inhibition and reward processing in pathological gamblers and people with obsessive compulsive disorder compared to healthy controls. Healthy participants and participants who are diagnosed with PG or OCD will undergo one fMRI scan. The brain scan will last about one and a half hours and will involve performing tasks while in the scanner.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • Male or female adults diagnosed with pathological gambling or obsessive compulsive disorder aged 18-55.
  • Subject has signed an informed consent form
  • Must provide contact information
  • Must be in generally good health
  • Must be willing and able to read written instructions and complete scales
  • Must be English speaking
  • In the opinion of the investigator, the subject is capable of complying with all study procedures

Pathological Gamblers only:

  • Current diagnosis of pathological gambling, supported by DSM-IV SCI-PG
  • Must score ≥ 5 on SOGS
  • Must score ≥ 2 on item number 1 on the G-SAS
  • Subjects must have a severity score of ≥ 4 (moderately ill) on the Clinical Global Impressions Scale - Severity (CGI-S)
  • Must score ≥ 10 on questions 1-5 on PG-Y-BOCS
  • Must score ≤ 15 on YMRS
  • Must have gambled once within past 2 weeks of Screening Visit.

Exclusion Criteria:

  • Subjects with a primary diagnosis of schizophrenia, personality disorder, or other psychotic disorders
  • Subjects with a primary diagnosis of an Axis I disorder that may require intervention
  • Must not score >24 on the Montgomery-Asberg Depression Rating Scale (MADRS) (pathological gamblers only)
  • Subjects who live in a restrictive environment
  • Subjects with a current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine
  • Subjects reporting a history of drug and/or alcohol dependence or abuse; subjects who report occasional drug use in the past will be discussed by a panel (consisting of Dr. Gilbert, Dr. Fan and Dr. Bartz), and will be considered for participation on a case by case basis
  • Subjects who have used psychotropic medications in the past week to six weeks (depending on the medication)
  • Subject has a positive drug urine screen
  • Female subjects who are pregnant
  • Subjects who report a history of severe liver, heart, or kidney disease because these conditions are associated with neurological sequella
  • Employees of the investigator or study center or their families
  • Finally, subjects who do not satisfy the following criteria will be excluded because they will be unable to undergo the MRI procedure. Specifically, subjects will be excluded who have:

    1. a pacemaker
    2. any implanted metallic chips in their head
    3. ever worked around a metal lathe or had a shrapnel (war or gun shot) wound/injury
    4. an implanted neuro-stimulatory or infusion/insulin pump
    5. any devices placed in their blood vessels
    6. any metal in/on their body
    7. kidney disease
    8. sickle-cell or hemolytic anemia
    9. claustrophobia
    10. any metallic tattoos
    11. any body piercing that cannot be removed
    12. dental braces
    13. any permanent make-up
    14. any cardiac stints
  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): NCT00211822


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Abbott
Investigators
Principal Investigator: Eric Hollander, MD Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
Responsible Party: Jennifer Bartz, PhD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00211822     History of Changes
Other Study ID Numbers: GCO#04-1034
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Icahn School of Medicine at Mount Sinai:
Pathological Gambling
Obsessive-Compulsive Disorder
Go No-go
Monetary incentives delay
fMRI

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Gambling
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Disruptive, Impulse Control, and Conduct Disorders