NCT01493362

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 15, 2014

Status Verified

November 1, 2011

Enrollment Period

5.9 years

First QC Date

December 14, 2011

Last Update Submit

August 14, 2014

Conditions

Eating Disorders

Keywords

Bulimia NervosaPET ImagingDopamine

Outcome Measures

Primary Outcomes (2)

  • D2 receptor density

    Measured at baseline

  • DA release in the striatum

    Measures after Mythlyphenidate challenge

Study Arms (2)

1

Participants with Bulimia Nervosa

2

Participants who are healthy controls

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 16, 2011

Study Start

January 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 15, 2014

Record last verified: 2011-11

Locations

US(1)