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Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00308776
  Purpose

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.


Condition Intervention
Bulimia Nervosa
Eating Disorders
Procedure: Cholescystokinin (CCK) infusion
Procedure: Saline infusion

MedlinePlus related topics:   Eating Disorders   

ChemIDplus related topics:   Sodium chloride    Cholecystokinin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa

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

Primary Outcome Measures:
  • Amount of food consumed after administration of CCK (measured upon study completion) [ Time Frame: Measured at Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:   32
Study Start Date:   October 2003
Estimated Study Completion Date:   July 2009
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive intravenous saline plus cholescystokinin.
Procedure: Cholescystokinin (CCK) infusion
Participants will 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 saline plus CCK.
2: Active Comparator
Participants will receive intravenous saline only.
Procedure: Saline infusion
Participants will 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 saline only.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308776

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

Locations
United States, New York
New York State Psychiatric Institute     Recruiting
      New York, New York, United States, 10032
      Principal Investigator: B. Timothy Walsh, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     B. Timothy Walsh, MD     New York State Psychiatric Institute at Columbia University Medical Center    
  More Information

Responsible Party:   New York State Psychiatric Institute ( B. Timothy Walsh, MD )
Study ID Numbers:   R01 MH42206-03, DATR A2-AID
First Received:   March 28, 2006
Last Updated:   March 28, 2008
ClinicalTrials.gov Identifier:   NCT00308776
Health Authority:   United States: Federal Government

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

Additional relevant MeSH terms:
Therapeutic Uses
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 18, 2008




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