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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by (Responsible Party): | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00304187 |
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 II |
| 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 |
| Enrollment: | 65 |
| 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: 1
Participants will take erythromycin.
|
Drug: Erythromycin
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
|
|
Placebo Comparator: 2
Participants will take matched placebo.
|
Drug: Placebo
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
|
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 follow these links:
http://clinicaltrials.gov/show/NCT00308776
http://clinicaltrials.gov/show/NCT00307190
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Eating Disorders Clinic, New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | B. T. Walsh, MD | New York State Psychiatric Institute at Columbia University Medical Center |
More Information
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00304187 History of Changes |
| Other Study ID Numbers: | R01 MH042206-05, DATR A2-AID |
| Study First Received: | March 15, 2006 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Federal Government |
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Binge-Eating Disorder |
|
Bulimia Bulimia Nervosa Binge-Eating Disorder Eating Disorders Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Erythromycin stearate Erythromycin |
Erythromycin Estolate Erythromycin Ethylsuccinate Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents |