Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | March 15, 2006 | ||||
Last Updated Date | April 20, 2009 | ||||
Start Date † | September 2004 | ||||
Current Primary Outcome Measures † |
|
||||
Original Primary Outcome Measures † |
|
||||
Change History | Complete list of historical versions of study NCT00304187 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in People With Bulimia Nervosa | ||||
Official Title † | Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa | ||||
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 follow these links: http://clinicaltrials.gov/show/NCT00308776 http://clinicaltrials.gov/show/NCT00307190 |
||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment | ||||
Condition † |
|
||||
Intervention † |
|
||||
Study Arms / Comparison Groups |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 96 | ||||
Estimated Completion Date | December 2009 | ||||
Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Female | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
|
||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00304187 | ||||
Responsible Party | B. Timothy Walsh, MD, The New York State Psychiatric Institute | ||||
Secondary IDs †† | DATR A2-AID | ||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | National Institute of Mental Health (NIMH) | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |