Pathological GamblingNCT00211822
Functional Magnetic Resonance Imaging (fMRI) Studies in Pathological Gambling (PG) and Obsessive-Compulsive Disorder (OCD)
An observational study of Pathological Gambling and Obsessive Compulsive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pathological Gambling, Obsessive Compulsive Disorder
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Being tested
- fMRI
- Keywords
- Pathological Gambling, Obsessive-Compulsive Disorder, Go No-go, Monetary incentives delay, fMRI
- Medical subject headings
- Gambling, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIProcedure or surgery
fMRI
| Study group | Role | What they receive |
|---|---|---|
| Pathologic Gamblers | Not described Receives: Procedure: fMRI | |
| Obsessive Compulsive Disorder | Not described Receives: Procedure: fMRI | |
| Healthy Controls | Not described Receives: Procedure: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI - go-nogo task
a measure of behavioral response inhibition
Measured: at baseline
fMRI - monetary incentive delay (MID) task
a measure of neural response to anticipating and receiving monetary rewards
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Enrollments closed after former PI Eric Hollander left institution. There are no results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Eric Hollander, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211822
- Sponsor's protocol ID
- GCO#04-1034
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Studies in Pathological Gambling and Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00211822
- Acronym / sponsor ID
- GCO#04-1034
- Keywords
- Pathological Gambling, Obsessive-Compulsive Disorder, Go No-go, Monetary incentives delay, fMRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollments closed after former PI Eric Hollander left institution. There are no results.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Nov 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pathologic Gamblers | – | Procedure: fMRI |
| Obsessive Compulsive Disorder | – | Procedure: fMRI |
| Healthy Controls | – | Procedure: fMRI |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIfMRI | Procedure or surgery | Healthy Controls, Obsessive Compulsive Disorder, Pathologic Gamblers |
Primary outcome
fMRI - go-nogo task
Time frame: at baseline
a measure of behavioral response inhibition
fMRI - monetary incentive delay (MID) task
Time frame: at baseline
a measure of neural response to anticipating and receiving monetary rewards
Results and safety
The study was stopped early (reason given: Enrollments closed after former PI Eric Hollander left institution. There are no results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathological Gambling and Obsessive Compulsive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollments closed after former PI Eric Hollander left institution. There are no results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI - go-nogo task (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2011.