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Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa
Official Title  Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
Brief Summary

This study will determine the effectiveness of administrating a dose of cholecystokinin during a binge eating episode in reducing this eating behavior in people with bulimia nervosa.

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. Cholecystokinin (CCK) is a hormone that is released by the small intestine, and functions as a trigger for digestion and hunger suppression. People with BN often have disturbances in the release of CCK, which may contribute to their binge eating behavior. This study will determine the effectiveness of administrating a dose of CCK during a binge eating episode in reducing this eating behavior in people with BN.

This study will enroll females with BN and healthy females without BN. Interested participants will first report to the study site for an interview about their feelings on their eating habits. If eligible, participants will report to the study site at 9 A.M. on 4 days. Upon arrival, they will receive a standardized breakfast of apple juice and an English muffin with butter. Participants will then return 2.5 hours later to start an IV and begin infusion with a normal saline solution. After 10 minutes of saline infusion, participants will eat a small bowl of tomato soup, followed 20 minutes later by a 15-minute infusion of either saline or saline plus CCK. Participants will then be given a meal of macaroni and beef. They will be alone in the room while eating, but will be monitored by TV camera. Nothing, however, will be taped or recorded. A tape recording will be used to instruct participants when to begin eating. Participants will be instructed to either eat until an assistant returns to the room, or eat as much as they can. Participants will also fill out questionnaires before and after each meal, and sometimes during a meal. The amount of food consumed after an infusion with CCK will be assessed upon study completion.

Study Phase
Study Type  Interventional
Study Design  Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Amount of food consumed after administration of CCK (measured upon study completion) [ Time Frame: Measured at Day 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Bulimia Nervosa
Eating Disorders
Intervention  Procedure: Cholescystokinin (CCK) infusion
Procedure: Saline infusion
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  32
Start Date  October 2003
Completion Date July 2009
Eligibility Criteria 

Inclusion Criteria:

  • Meets DSM-IV criteria for BN
  • BN duration of more than 1 year
  • Self-induces vomiting
  • Weighs between 80 and 120% of ideal body weight

Exclusion Criteria:

  • Significant medical illness
  • Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by DSM-IV-TR criteria
  • 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 the study procedures
  • At risk for suicide, as defined by the expression of an imminent plan or attempt within the 6 months prior to study entry
  • Currently taking psychotropic medications or medications that affect gastrointestinal function
  • Moderate to severe depression, as defined by a score of greater than 28 on the Hamilton Depression Rating Scale
  • Drug or alcohol abuse within the 3 months prior to study entry
  • Pregnant, planning to become pregnant, or lactating
  • Body mass index (BMI) of less than 18 (underweight)
Gender Female
Ages 18 Years to 55 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Amanda J. Brown, BA     212-543-5151     edru@pi.cpmc.columbia.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00308776
Organization ID R01 MH42206-03
Secondary IDs †† DATR A2-AID
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     B. Timothy Walsh, MD     New York State Psychiatric Institute at Columbia University Medical Center    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  March 28, 2006
Last Updated Date March 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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