Phase 2
N=29
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Bulimia Nervosa · Eating Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00304187 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Binge Frequency — 10.4; 11.3 Binge Episodes/Week — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erythromycin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Frequency |
10.4; 11.3 | <.05 sig |
| PRIMARY Percent of Meal Remaining/Minute |
-.339; -.177 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00304187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.