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

Obsessive Compulsive Disorder Clinical Trial

Official title:

fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00211822
• Other study ID #: GCO#04-1034
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 13, 2011
• Start date: November 2004
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Compulsive Behavior
• Gambling
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Pathological Gambling

Intervention

Procedure:
• fMRI
fMRI

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI - go-nogo task	a measure of behavioral response inhibition	at baseline	No
Primary	fMRI - monetary incentive delay (MID) task	a measure of neural response to anticipating and receiving monetary rewards	at baseline	No

External Links

•   Mount Sinai School of Medicine Compulsive, Impulsive and Anxiety Disorders Program