NCT00304187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 30, 2013

Completed
Last Updated

August 20, 2018

Status Verified

June 1, 2018

Enrollment Period

7.2 years

First QC Date

March 15, 2006

Results QC Date

April 24, 2013

Last Update Submit

August 16, 2018

Conditions

Bulimia NervosaEating Disorders

Keywords

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (2)

  • Binge Frequency

    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.

    Measured at Week 7

  • Percent of Meal Remaining/Minute

    percent of meal remaining/minute

    Measured at Week 7

Study Arms (2)

Erythromycin

EXPERIMENTAL

Subjects with Bulimia Nervosa will take erythromycin.

Drug: Erythromycin

Placebo

PLACEBO COMPARATOR

Participants will take matched placebo.

Drug: Placebo

Interventions

ErythromycinDRUG

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

Also known as: E-mycin, Eryc, Ery-tab
Erythromycin
PlaceboDRUG

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

Also known as: inactive substance
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets criteria for bulimia nervosa
  • Duration of illness is greater than 1 year
  • Self-induces vomiting
  • Weighs 80%-120 % of ideal weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bulimia NervosaFeeding and Eating DisordersBinge-Eating Disorder

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Michael Devlin
Organization
New York State Psychiatric Institute
mjd5@columbia.edu
212-543-5748

Study Officials

  • B. T. Walsh, MD

    New York State Psychiatric Institute at Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

September 1, 2004

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

August 20, 2018

Results First Posted

July 30, 2013

Record last verified: 2018-06

Locations

US(1)