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:
Collaborator:
Abbott
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211822
First received: September 13, 2005
Last updated: July 13, 2011
Last verified: July 2011
  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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • fMRI - go-nogo task [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    a measure of behavioral response inhibition

  • fMRI - monetary incentive delay (MID) task [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: NCT00211822

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

Additional Information:
No publications provided

Responsible Party: Jennifer Bartz, PhD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00211822     History of Changes
Other Study ID Numbers: GCO#04-1034
Study First Received: September 13, 2005
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Gambling
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Impulse Control Disorders
Mental Disorders
Anxiety Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 29, 2014