Eating DisordersNCT01493362
Imaging the Dopamine Systems in Bulimia Nervosa
An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will use positron emission tomography imaging to investigate the dopamine systems in people with bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2013
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will include people with bulimia nervosa seeking inpatient or outpatient treatment and people who will act as healthy control participants
Who may be able to join
- Participants with BN:
- Meets DSM-IV criteria for BN
- Sufficiently medically and psychiatrically stable to participate in research
- Health Control Participants:
- No current or past psychiatric illness
- Between 80% and 120% of ideal body weight
Who cannot join
- All participants:
- Current use of psychotropic medication such as anti psychotics or antidepressants
- Pregnant or breastfeeding
- history of substance abuse
- Significant medical illness
- High blood pressure (resting systolic blood pressure greater than 150mmHg and diastolic blood pressure greater that 90 mmHg)
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- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV
- Metal implants or paramagnetic objects contained within the body that may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to specified reference book guidelines
- Exposed to radiation in the workplace or has had a nuclear medicine procedure during the 1 year before study entry
- Previous adverse reaction to psycho stimulants
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
This study will use positron emission tomography imaging to investigate the dopamine systems in people with bulimia nervosa.
- Conditions
- Eating Disorders
- Keywords
- Bulimia Nervosa, PET Imaging, Dopamine
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants with Bulimia Nervosa | |
| 2 | Participants who are healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
D2 receptor density
Measured: Measured at baseline
DA release in the striatum
Measured: Measures after Mythlyphenidate challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493362
- Sponsor's protocol ID
- #5175
- Other IDs
- R01MH079397
- Status last verified
- Nov 2011
- First submitted
- 14 Dec 2011
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Dopamine Systems in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT01493362
- Acronym / sponsor ID
- #5175
- Conditions
- Eating Disorders
- Keywords
- Bulimia Nervosa, PET Imaging, Dopamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Dec 2011 (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 use positron emission tomography imaging to investigate the dopamine systems in people with bulimia nervosa.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants with Bulimia Nervosa |
| 2 | – | –Participants who are healthy controls |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include people with bulimia nervosa seeking inpatient or outpatient treatment and people who will act as healthy control participants
Key inclusion criteria (6 listed)
- Meets DSM-IV criteria for BN
- Sufficiently medically and psychiatrically stable to participate in research
- No current or past psychiatric illness
- Between 80% and 120% of ideal body weight
Key exclusion criteria (10 listed)
- Current use of psychotropic medication such as anti psychotics or antidepressants
- Pregnant or breastfeeding
- history of substance abuse
- Significant medical illness
- High blood pressure (resting systolic blood pressure greater than 150mmHg and diastolic blood pressure greater that 90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
D2 receptor density
Time frame: Measured at baseline
DA release in the striatum
Time frame: Measures after Mythlyphenidate challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Eating Disorders, run by New York State Psychiatric Institute 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 15 Aug 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
D2 receptor density (time frame: Measured 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 15 Aug 2014.