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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH042206-05 | U.S. NIH Grant/Contract | View source | |
| DATR A2-AID | Other Identifier | NIH Adult Translational Research and Treatment Development |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Experimental | Subjects with Bulimia Nervosa will take erythromycin. |
|
| Placebo | Placebo Comparator | Participants will take matched placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at Week 7 |
| Percent of Meal Remaining/Minute | percent of meal remaining/minute | Measured at Week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B. T. Walsh, MD | New York State Psychiatric Institute at Columbia University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eating Disorders Clinic, New York State Psychiatric Institute | New York | New York | 10032 | United States |
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Eating Disorders Research Clinic at New York State Psychiatric Institute
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythromycin | Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks |
| FG001 | Placebo | Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythromycin | Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks |
| BG001 | Placebo | Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Binge Episodes/Week | Measured at Week 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erythromycin | Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Devlin | New York State Psychiatric Institute | 212-543-5748 | mjd5@columbia.edu |
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| ID | Term |
|---|---|
| D052018 | Bulimia Nervosa |
| D001068 | Feeding and Eating Disorders |
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo, 250 mg or 500 mg, three times a day for 6 weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percent of Meal Remaining/Minute | percent of meal remaining/minute | Posted | Mean | Standard Error | percent of meal remaining/minute | Measured at Week 7 |
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| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks | 0 | 14 | 0 | 14 |
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