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

New York State Psychiatric Institute

Status and phase

Completed

Phase 2

Conditions

Bulimia Nervosa

Eating Disorders

Treatments

Drug: Placebo

Drug: Erythromycin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00304187

#4902

R01MH042206-05 (U.S. NIH Grant/Contract)

DATR A2-AID

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts 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