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Motivating Factors That Play a Role in Bulimia Nervosa

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00304174
First received: March 15, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Bulimia Nervosa
Eating Disorders
Behavioral: Motivation to eat

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Translational Research on Eating Disorders: Behavioral Assessment of Motivation to Eat

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Breakpoint [ Time Frame: Measured at Day 3 ] [ Designated as safety issue: No ]
  • Total work performed on progressive task [ Time Frame: Measured at Day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2005
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with bulimia nervosa
Participants with bulimia nervosa
Behavioral: Motivation to eat
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 weight
Controls without bulimia nervosa
Behavioral: Motivation to eat
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.

Detailed Description:

Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Similar to drug abuse disorders, food-related thinking and disordered eating behavior can interfere with other occupational and social activities, as well. 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.

Interested participants will first report to the study site for a screening visit, during which they will be assessed for eligibility using blood tests and an interview. Eligible participants will return to the study site on 3 additional days. Participants will be asked to refrain from eating or drinking between 10 P.M. each night before reporting to the study site and 10 A.M. the next day. Each day, participants will receive breakfast, after which they will not be allowed to eat or drink until the end of the day. Participants will then 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. A private bathroom will be available if needed. All participants, including those who did not meet criteria for participation, will be offered treatment at the study clinic once the study is complete.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  • History of any eating disorder
  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: NCT00304174

Locations
United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: B. T. Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00304174     History of Changes
Other Study ID Numbers: #5049/#6178R, R21MH065024-05, DNBBS 72-NBR
Study First Received: March 15, 2006
Last Updated: October 31, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014