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

July 13, 2011 updated by: Icahn School of Medicine at Mount Sinai

fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder

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.

Study Overview

Status

Terminated

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Controls
fMRI
Pathologic Gamblers
fMRI
Obsessive Compulsive Disorder
fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI - go-nogo task
Time Frame: at baseline
a measure of behavioral response inhibition
at baseline
fMRI - monetary incentive delay (MID) task
Time Frame: at baseline
a measure of neural response to anticipating and receiving monetary rewards
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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