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

Terminated

• Conditions: Obsessive Compulsive Disorder; Pathological Gambling
• Interventions: Procedure: fMRI

• Registration Number: NCT00211822
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	fMRI	-
Pathologic Gamblers	fMRI	-
Obsessive Compulsive Disorder	fMRI	-

Primary Outcome Measures

Name	Time	Method
fMRI - monetary incentive delay (MID) task	at baseline	a measure of neural response to anticipating and receiving monetary rewards
fMRI - go-nogo task	at baseline	a measure of behavioral response inhibition

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States