Bulimia Nervosa, Eating Disorders
Conditions
Keywords
Binge-Eating Disorder
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.
Interventions
DRUGErythromycin
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
DRUGPlacebo
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Frequency | 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. |
| Percent of Meal Remaining/Minute | Measured at Week 7 | percent of meal remaining/minute |
Countries
United States
Participant flow
Recruitment details
Eating Disorders Research Clinic at New York State Psychiatric Institute
Participants by arm
| Arm | Count |
|---|---|
| Erythromycin Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks | 15 |
| Placebo Participants will take matched placebo.
Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Placebo | Erythromycin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 29 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 3 | 24 years STANDARD_DEVIATION 3 | 24 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Measured at Week 7
Population: Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erythromycin | Binge Frequency | 10.4 Binge Episodes/Week | Standard Deviation 8.7 |
| Placebo | Binge Frequency | 11.3 Binge Episodes/Week | Standard Deviation 10.9 |
p-value: <0.05t-test, 2 sided
Primary
Percent of Meal Remaining/Minute
percent of meal remaining/minute
Time frame: Measured at Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erythromycin | Percent of Meal Remaining/Minute | -.339 percent of meal remaining/minute | Standard Error 0.14 |
| Placebo | Percent of Meal Remaining/Minute | -.177 percent of meal remaining/minute | Standard Error 0.122 |