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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

March 15, 2006
October 31, 2013
May 2005
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00304174 on ClinicalTrials.gov Archive Site
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Motivating Factors That Play a Role in Bulimia Nervosa
Translational Research on Eating Disorders: Behavioral Assessment of Motivation to Eat

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Probability Sample

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

  • Bulimia Nervosa
  • Eating Disorders
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.
  • Subjects with bulimia nervosa
    Participants with bulimia nervosa
    Intervention: Behavioral: Motivation to eat
  • Controls between 80-120% of ideal weight
    Controls without bulimia nervosa
    Intervention: Behavioral: Motivation to eat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
June 2017
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00304174
#5049/#6178R, R21MH065024-05, DNBBS 72-NBR
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: B. T. Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
New York State Psychiatric Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP