- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211822
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:
- 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
- an implanted neuro-stimulatory or infusion/insulin pump
- any devices placed in their blood vessels
- any metal in/on their body
- kidney disease
- sickle-cell or hemolytic anemia
- claustrophobia
- any metallic tattoos
- any body piercing that cannot be removed
- dental braces
- any permanent make-up
- 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.
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO#04-1034
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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