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Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa

Primary Purpose

Bulimia Nervosa, Eating Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erythromycin
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Binge-Eating Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Meets criteria for bulimia nervosa Duration of illness is greater than 1 year Self-induces vomiting Weighs 80%-120 % of ideal weight Exclusion Criteria: Significant medical illness Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by American Psychiatric Association criteria Moderate to severe depression, as defined by a score greater than 18 on the Hamilton Depression Scales Current diagnosis of organic mental disorder, factitious disorder, or malingering History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures At risk for suicide Current psychotropic medications and current medications that affect GI function or that inhibit or induce cytochrome three A gene expression Currently pregnant, lactating, or planning to become pregnant Drug or alcohol abuse within the 3 months prior to study entry Abnormal EKG at baseline or 1 week following each upward dosage adjustment Anemia Known intolerance to erythromycin, or related antibiotics Abnormal results on liver function tests Electrolyte abnormalities

Sites / Locations

  • Eating Disorders Clinic, New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erythromycin

Placebo

Arm Description

Subjects with Bulimia Nervosa will take erythromycin.

Participants will take matched placebo.

Outcomes

Primary Outcome Measures

Binge Frequency
Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.
Percent of Meal Remaining/Minute
percent of meal remaining/minute

Secondary Outcome Measures

Full Information

First Posted
March 15, 2006
Last Updated
August 16, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00304187
Brief Title
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Official Title
Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 the antibiotic erythromycin in enhancing gastrointestinal function and decreasing the frequency of binge eating 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. Although there is significant existing knowledge about the characteristics and treatment of BN, more information is needed about gastrointestinal (GI) function and its effect on binge eating behavior. This study will determine the effectiveness of the antibiotic erythromycin in enhancing GI function and decreasing the frequency of binge eating in people with BN. Participants in this 8-week, double-blind study will first undergo gastric emptying and GI hormone release testing for 1 day. Within 1 week of completing these pre-treatment tests, participants will be randomly assigned to receive either erythromycin or placebo for 6 weeks. Upon medication assignment, participants will meet with a psychiatrist to receive their assigned medication. Participants will receive medication at weekly study visits. Medication dosage will be increased if symptoms do not improve, or decreased if adverse medication side effects are reported. A final day of gastric emptying and GI hormone release testing, as well as routine blood tests, will take place in Week 7, after 6 weeks of medication treatment. Participants' weight will be measured at Weeks 1, 4, and 7. Participants will also receive an EKG 1 week after each upward dosage adjustment. Patients will be informed of their medication assignment at the Week 7 study visit, and will be referred to a non-study clinician for further treatment. For information on related studies, please see NCT00308776 and NCT00307190.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythromycin
Arm Type
Experimental
Arm Description
Subjects with Bulimia Nervosa will take erythromycin.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take matched placebo.
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Other Intervention Name(s)
E-mycin, Eryc, Ery-tab
Intervention Description
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
inactive substance
Intervention Description
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Primary Outcome Measure Information:
Title
Binge Frequency
Description
Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.
Time Frame
Measured at Week 7
Title
Percent of Meal Remaining/Minute
Description
percent of meal remaining/minute
Time Frame
Measured at Week 7

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: Meets criteria for bulimia nervosa Duration of illness is greater than 1 year Self-induces vomiting Weighs 80%-120 % of ideal weight Exclusion Criteria: Significant medical illness Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by American Psychiatric Association criteria Moderate to severe depression, as defined by a score greater than 18 on the Hamilton Depression Scales Current diagnosis of organic mental disorder, factitious disorder, or malingering History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures At risk for suicide Current psychotropic medications and current medications that affect GI function or that inhibit or induce cytochrome three A gene expression Currently pregnant, lactating, or planning to become pregnant Drug or alcohol abuse within the 3 months prior to study entry Abnormal EKG at baseline or 1 week following each upward dosage adjustment Anemia Known intolerance to erythromycin, or related antibiotics Abnormal results on liver function tests Electrolyte abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. T. Walsh, MD
Organizational Affiliation
New York State Psychiatric Institute at Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eating Disorders Clinic, New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa

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