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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00304187
First received: March 15, 2006
Last updated: June 21, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Bulimia Nervosa
Eating Disorders
Drug: Erythromycin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Binge Frequency [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]
    Binge frequency wass 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.

  • Gastric Emptying Rate [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: September 2004
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304187

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

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00304187     History of Changes
Other Study ID Numbers: #4902, R01MH042206-05, DATR A2-AID
Study First Received: March 15, 2006
Results First Received: April 24, 2013
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Binge-Eating Disorder

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Bulimia Nervosa
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014