NCT00304174

Brief Summary

This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

9.1 years

First QC Date

March 15, 2006

Last Update Submit

May 23, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Breakpoint

    Measured at Day 3

  • Total work performed on progressive task

    Measured at Day 3

Study Arms (2)

Subjects with bulimia nervosa

Participants with bulimia nervosa

Behavioral: Motivation to eat

Controls between 80-120% of ideal weight

Controls without bulimia nervosa

Behavioral: Motivation to eat

Interventions

Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.

Controls between 80-120% of ideal weightSubjects with bulimia nervosa

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants who meet DSM-IV criteria for bulimia nervosa and control participants who weigh between 80 and 120% of ideal weight

You may qualify if:

  • Participants with Bulimia Nervosa:
  • Meets DSM-IV criteria for bulimia nervosa
  • Duration of illness is greater than 1 year
  • Self-induces vomiting
  • Weighs between 80% and 120% of ideal weight
  • Female
  • Control Group:
  • Weighs between 80% and 120% of ideal weight
  • Female
  • Ages 18-45
  • No current or past psychiatric illness
  • No history of eating disorder

You may not qualify if:

  • Participants with Bulimia Nervosa:
  • Significant medical illness
  • Current Axis I illness other than major depression
  • Severe or very severe depression
  • At risk for suicide
  • Currently taking medication
  • History of drug or alcohol abuse within the 6 months prior to study entry
  • Pregnant
  • Male
  • Control Group:
  • Significant medical illness
  • Currently taking medication
  • History of drug or alcohol abuse within the 6 months prior to study entry
  • Pregnant
  • Male
  • +1 more criteria

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

MeSH Terms

Conditions

Bulimia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

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 15, 2006

First Posted

March 17, 2006

Study Start

May 1, 2005

Primary Completion

June 1, 2014

Study Completion

May 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations