Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304187
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2006-03-15
Brief Title:
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A2-AID | OTHER | NIH Adult Translational Research and Treatment Development | httpsreporternihgovquickSearchR01MH042206-05 |
| R01MH042206-05 | NIH | None | None |