Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in People With Bulimia Nervosa - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00304187

Purpose

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	Intervention	Phase
Bulimia Nervosa Eating Disorders	Drug: Erythromycin Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Eating Disorders

Drug Information available for: Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Binge frequency [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]
Gastric emptying rate [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	September 2004
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will take erythromycin.	Drug: Erythromycin Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
Placebo Comparator: 2 Participants will take matched placebo.	Drug: Placebo Placebo, 250 mg or 500 mg, three times a day for 6 weeks

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

Eligibility

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

Criteria

Inclusion Criteria:

Meets DSM-IV 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 DSM-IV-TR criteria
Moderate to severe depression, as defined by a score greater than 18 on the Hamilton Depression Scales
Current DSM-IV-TR 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 CYP3A 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304187

Locations

United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

B. T. Walsh, MD

New York State Psychiatric Institute at Columbia University Medical Center

More Information

No publications provided

Responsible Party:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00304187 History of Changes
Other Study ID Numbers:	R01 MH042206-05, DATR A2-AID
Study First Received:	March 15, 2006
Last Updated:	December 14, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Binge-Eating Disorder

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Erythromycin stearate
Erythromycin

Erythromycin Estolate
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012