Imaging the Dopamine Systems in Bulimia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by New York State Psychiatric Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01493362
First received: December 14, 2011
Last updated: August 8, 2013
Last verified: November 2011
  Purpose

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


Condition
Eating Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Imaging the Dopamine Systems in Bulimia Nervosa

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • D2 receptor density [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • DA release in the striatum [ Time Frame: Measures after Mythlyphenidate challenge ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Participants with Bulimia Nervosa
2
Participants who are healthy controls

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493362

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01493362     History of Changes
Other Study ID Numbers: #5175, R01MH079397
Study First Received: December 14, 2011
Last Updated: August 8, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Bulimia Nervosa
PET Imaging
Dopamine

Additional relevant MeSH terms:
Bulimia
Eating Disorders
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Dopamine
Dopamine Agents
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 10, 2014