NCT00307190

Brief Summary

This study will determine whether the disturbances in cholecystokinin release and gastric emptying that occur in people with binge eating disorder are similar to those that occur in people with bulimia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2004

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

October 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

5 years

First QC Date

March 23, 2006

Last Update Submit

May 25, 2012

Conditions

Keywords

BED

Study Arms (2)

Binge Eating Disorder

Women with Binge Eating Disorder

Controls

Weight, age, and gender-matched control subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, obese women between ages 18 and 60 with and without Binge Eating Disorder

You may qualify if:

  • For all participants:
  • Obese (body mass index (BMI) greater than 35 kg/m2)
  • For participants with BED:
  • Meets DSM-IV criteria for BED
  • BED duration of at least 1 year
  • For healthy participants:
  • Weight close to that of participants with BED

You may not qualify if:

  • Current or past diagnosis of BN, or any binge eating or self-induced vomiting
  • Significant medical illness
  • Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
  • Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
  • History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
  • At risk for suicide
  • Currently taking psychotropic medication or medication that is known to affect appetite or gastric functioning
  • History of drug or alcohol abuse within the 3 months prior to study entry
  • Pregnant, planning to become pregnant, or lactating
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Binge-Eating DisorderObesityFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • B. T. Walsh, MD

    New York State Psychiatric Institute at Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

October 1, 2004

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations