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Motivating Factors That Play a Role in Bulimia Nervosa
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00304174
  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

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Translational Research on Eating Disorders: Behavioral Assessment of Motivation to Eat

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 32
Study Start Date: May 2005
Estimated Study Completion Date: February 2009
Groups/Cohorts Assigned Interventions
1
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.
2
Control participants without bulimia nervose who weigh between 80% and 120% of ideal weight
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

Control Group:

  • Weighs between 80% and 120% of ideal weight

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

Control Group:

  • Significant medical illness
  • Currently taking medication
  • History of drug or alcohol abuse within the 6 months prior to study entry
  • Pregnant
  • Current or history of psychiatric illness
  • History of any eating disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304174

Contacts
Contact: Amanda J. Brown, BA 212-543-5151 edru@pi.cpmc.columbia.edu

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

Responsible Party: The New York State Psychiatric Institute ( B. Timothy Walsh, MD )
Study ID Numbers: R21 MH65024-05, DNBBS 72-NBR
Study First Received: March 15, 2006
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00304174  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Signs and Symptoms
Bulimia Nervosa
Signs and Symptoms, Digestive
Mental Disorders
Bulimia
Eating Disorders
Hyperphagia

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009