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Trial record 78 of 593 for:    binge eating disorder

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bulimia Nervosa
Eating Disorders
Interventions Drug: Erythromycin
Drug: Placebo
Enrollment 29
Recruitment Details Eating Disorders Research Clinic at New York State Psychiatric Institute
Pre-assignment Details  
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description

Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks

Participants will take matched placebo.

Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks

Period Title: Overall Study
Started 15 14
Completed 13 13
Not Completed 2 1
Arm/Group Title Erythromycin Placebo Total
Hide Arm/Group Description

Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks

Participants will take matched placebo.

Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 15 14 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 29 participants
24  (3) 24  (3) 24  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
Female
15
 100.0%
14
 100.0%
29
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 29 participants
15 14 29
1.Primary Outcome
Title Binge Frequency
Hide Description 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.
Time Frame Measured at Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks

Participants will take matched placebo.

Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Binge Episodes/Week
10.4  (8.7) 11.3  (10.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erythromycin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Percent of Meal Remaining/Minute
Hide Description percent of meal remaining/minute
Time Frame Measured at Week 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description:

Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin: Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks

Participants will take matched placebo.

Placebo: Placebo, 250 mg or 500 mg, three times a day for 6 weeks

Overall Number of Participants Analyzed 13 13
Mean (Standard Error)
Unit of Measure: percent of meal remaining/minute
-.339  (.14) -.177  (.122)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erythromycin Placebo
Hide Arm/Group Description

Subjects with Bulimia Nervosa will take erythromycin.

Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks

Participants will take matched placebo.

Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks

All-Cause Mortality
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erythromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michael Devlin
Organization: New York State Psychiatric Institute
Phone: 212-543-5748
Responsible Party: B. Timothy Walsh, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00304187     History of Changes
Other Study ID Numbers: #4902
R01MH042206-05 ( U.S. NIH Grant/Contract )
DATR A2-AID ( Other Identifier: NIH Adult Translational Research and Treatment Development )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: April 24, 2013
Results First Posted: July 30, 2013
Last Update Posted: August 20, 2018