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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00304187
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : July 30, 2013
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
B. Timothy Walsh, New York State Psychiatric Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Eating Disorders Drug: Erythromycin Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
Study Start Date : September 2004
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Erythromycin
Subjects with Bulimia Nervosa will take erythromycin.
 Drug: Erythromycin
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
Other Names:
  • E-mycin
  • Eryc
  • Ery-tab
Placebo Comparator: Placebo
Participants will take matched placebo.
 Drug: Placebo
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Other Name: inactive substance


Outcome Measures
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Primary Outcome Measures :
  1. Binge Frequency [ Time Frame: Measured at Week 7 ]
    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.

  2. Percent of Meal Remaining/Minute [ Time Frame: Measured at Week 7 ]
    percent of meal remaining/minute


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304187


Locations
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United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: B. T. Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
More Information
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Responsible Party: B. Timothy Walsh, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00304187    
Other Study ID Numbers: #4902
R01MH042206-05 ( U.S. NIH Grant/Contract )
DATR A2-AID ( Other Identifier: NIH Adult Translational Research and Treatment Development )
First Posted: March 17, 2006    Key Record Dates
Results First Posted: July 30, 2013
Last Update Posted: August 20, 2018
Last Verified: June 2018
Keywords provided by B. Timothy Walsh, New York State Psychiatric Institute:
Binge-Eating Disorder
Additional relevant MeSH terms:
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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Erythromycin
Erythromycin Estolate
 Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action