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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01493362
Other study ID # #5175
Secondary ID R01MH079397
Status Completed
Phase N/A
First received December 14, 2011
Last updated August 14, 2014
Start date January 2008
Est. completion date December 2013

Study information

Verified date November 2011
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will use positron emission tomography imaging to investigate the dopamine systems in people with bulimia nervosa.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary D2 receptor density Measured at baseline No
Primary DA release in the striatum Measures after Mythlyphenidate challenge No
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