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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00304187
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 29
• Location: 1
• Arms: 2
• Duration (Months): 86
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bulimia Nervosa; Eating Disorders	Drug: Erythromycin; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erythromycin Subjects with Bulimia Nervosa will take erythromycin.	Drug: Erythromycin; Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks; Other Names: E-mycin Eryc Ery-tab
Placebo Comparator: Placebo Participants will take matched placebo.	Drug: Placebo; Placebo, 250 mg or 500 mg, three times a day for 6 weeks; Other Names: inactive substance

Outcome Measures

Primary Outcome Measures

1. Binge Frequency [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.

2. Percent of Meal Remaining/Minute [Measured at Week 7]

   percent of meal remaining/minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eating Disorders Clinic, New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: B. T. Walsh, MD, New York State Psychiatric Institute at Columbia University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: B. Timothy Walsh, Research Scientist, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00304187
• Other Study ID Numbers: #4902; R01MH042206-05; DATR A2-AID
• First Posted: Mar 17, 2006
• Last Update Posted: Aug 20, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by B. Timothy Walsh, Research Scientist, New York State Psychiatric Institute: Binge-Eating Disorder
• Additional relevant MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Study Results

Participant Flow

Recruitment Details	Eating Disorders Research Clinic at New York State Psychiatric Institute

Arm/Group Title	Erythromycin	Placebo
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

Baseline Characteristics

Arm/Group Title	Erythromycin	Placebo	Total
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 Participants	15	14	29
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	14 100%	29 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24 (3)	24 (3)	24 (3)
Sex: Female, Male (Count of Participants)
Female	15 100%	14 100%	29 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	14 100%	29 100%

Outcome Measures

1. Primary Outcome

Title	Binge Frequency
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

Outcome Measure Data

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
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
Measure Participants	13	13
Mean (Standard Deviation) [Binge Episodes/Week]	10.4 (8.7)	11.3 (10.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erythromycin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Percent of Meal Remaining/Minute
Description	percent of meal remaining/minute
Time Frame	Measured at Week 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erythromycin	Placebo
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
Measure Participants	13	13
Mean (Standard Error) [percent of meal remaining/minute]	-.339 (.14)	-.177 (.122)

Adverse Events

Arm/Group Title	Erythromycin		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Erythromycin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Erythromycin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.