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Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

Primary Purpose

Bulimia Nervosa, Eating Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecystokinin (CCK) infusion
Saline infusion
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bulimia Nervosa

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria for Patients with BN: 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 for Patients with BN: 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) Inclusion Criteria for Normal Weight Controls: No current or past psychiatric history No history of binge eating or vomiting 80-120% of ideal body weight Exclusion Criteria for Normal Weight Controls: Significant medical illness Current psychotropic medications and current medications that affect GI function Drug or alcohol abuse in last 3 months Pregnancy, planning to become pregnant or laction

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecystokinin

Saline

Arm Description

Participants will receive intravenous saline plus cholescystokinin.

Participants will receive intravenous saline only.

Outcomes

Primary Outcome Measures

Amount of food consumed after administration of CCK (measured upon study completion)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2006
Last Updated
May 25, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00308776
Brief Title
Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa
Official Title
Effect of Cholecystokinin on Binge Eating in Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit subjects
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. For information on related studies, please follow these links: http://clinicaltrials.gov/show/NCT00307190 http://clinicaltrials.gov/show/NCT00304187

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Eating Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecystokinin
Arm Type
Experimental
Arm Description
Participants will receive intravenous saline plus cholescystokinin.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Participants will receive intravenous saline only.
Intervention Type
Procedure
Intervention Name(s)
Cholecystokinin (CCK) infusion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Saline infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of food consumed after administration of CCK (measured upon study completion)
Time Frame
Measured at Day 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients with BN: 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 for Patients with BN: 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) Inclusion Criteria for Normal Weight Controls: No current or past psychiatric history No history of binge eating or vomiting 80-120% of ideal body weight Exclusion Criteria for Normal Weight Controls: Significant medical illness Current psychotropic medications and current medications that affect GI function Drug or alcohol abuse in last 3 months Pregnancy, planning to become pregnant or laction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Timothy Walsh, MD
Organizational Affiliation
New York State Psychiatric Institute at Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa

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