- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493362
Imaging the Dopamine Systems in Bulimia Nervosa
August 14, 2014 updated by: New York State Psychiatric Institute
This study will use positron emission tomography imaging to investigate the dopamine systems in people with bulimia nervosa.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
33
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, 10032
- New York State Psychiatric Institute
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
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
Exclusion Criteria:
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)
- 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
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 |
|---|
|
1
Participants with Bulimia Nervosa
|
|
2
Participants who are healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
D2 receptor density
Time Frame: Measured at baseline
|
Measured at baseline
|
|
DA release in the striatum
Time Frame: Measures after Mythlyphenidate challenge
|
Measures after Mythlyphenidate challenge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
January 1, 2008
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 14, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (Estimate)
December 16, 2011
Study Record Updates
Last Update Posted (Estimate)
August 15, 2014
Last Update Submitted That Met QC Criteria
August 14, 2014
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5175
- R01MH079397 (U.S. NIH Grant/Contract)
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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