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

NCT00211822 | Terminated

• 1 other identifier: GCO#04-1034
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pathological Gambling; Obsessive Compulsive Disorder

Keywords

Pathological Gambling; Obsessive-Compulsive Disorder; Go No-go; Monetary incentives delay; fMRI

Outcome Measures

Primary Outcomes (2)

• fMRI - go-nogo task

  a measure of behavioral response inhibition

  at baseline

• fMRI - monetary incentive delay (MID) task

  a measure of neural response to anticipating and receiving monetary rewards

  at baseline

Study Arms (3)

Pathologic Gamblers

Procedure: fMRI

Obsessive Compulsive Disorder

Procedure: fMRI

Healthy Controls

Procedure: fMRI

Interventions

fMRI PROCEDURE

fMRI

Healthy Controls; Obsessive Compulsive Disorder; Pathologic Gamblers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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.

You may not qualify if:

• 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:
• a pacemaker
• any implanted metallic chips in their head
• ever worked around a metal lathe or had a shrapnel (war or gun shot) wound/injury

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Abbott: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Gambling; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Eric Hollander, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

US (1)