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Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT00304187
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : July 30, 2013
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
B. Timothy Walsh, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE March 15, 2006
First Posted Date  ICMJE March 17, 2006
Results First Submitted Date  ICMJE April 24, 2013
Results First Posted Date  ICMJE July 30, 2013
Last Update Posted Date August 20, 2018
Study Start Date  ICMJE September 2004
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Binge Frequency [ Time Frame: Measured at Week 7 ]
    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.
  • Percent of Meal Remaining/Minute [ Time Frame: Measured at Week 7 ]
    percent of meal remaining/minute
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2006)
  • Binge Frequency
  • Gastric emptying rate (measured at Week 7)
Change History Complete list of historical versions of study NCT00304187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Official Title  ICMJE 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 see NCT00308776 and NCT00307190.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bulimia Nervosa
  • Eating Disorders
Intervention  ICMJE
  • Drug: Erythromycin
    Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
    Other Names:
    • E-mycin
    • Eryc
    • Ery-tab
  • Drug: Placebo
    Placebo, 250 mg or 500 mg, three times a day for 6 weeks
    Other Name: inactive substance
Study Arms  ICMJE
  • Experimental: Erythromycin
    Subjects with Bulimia Nervosa will take erythromycin.
    Intervention: Drug: Erythromycin
  • Placebo Comparator: Placebo
    Participants will take matched placebo.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2013)
29
Original Enrollment  ICMJE
 (submitted: March 15, 2006)
96
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00304187
Other Study ID Numbers  ICMJE #4902
R01MH042206-05 ( U.S. NIH Grant/Contract )
DATR A2-AID ( Other Identifier: NIH Adult Translational Research and Treatment Development )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party B. Timothy Walsh, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: B. T. Walsh, MD New York State Psychiatric Institute at Columbia University Medical Center
PRS Account New York State Psychiatric Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP