Clinical trial NCT00211822: Functional Magnetic Resonance Imaging (fMRI) Studies in Pathological Gambling (PG) and Obsessive-Compulsive Disorder (OCD)
Official title: fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pathological Gambling
Obsessive Compulsive Disorder
Keywords: Pathological Gambling
Obsessive-Compulsive Disorder
Go No-go
Monetary incentives delay
fMRI
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-21
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

Eligibility 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

Primary outcomes:
measure: fMRI - go-nogo task
timeFrame: at baseline
measure: fMRI - monetary incentive delay (MID) task
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: