Bulimia NervosaPhase 2NCT00304187
Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
A Phase 2 study testing Erythromycin in people with Bulimia Nervosa and Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Eating Disorders
- What is being tested?
- Erythromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets criteria for bulimia nervosa
- Duration of illness is greater than 1 year
- Self-induces vomiting
- Weighs 80%-120 % of ideal weight
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
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.
Read the 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.
- Conditions
- Bulimia Nervosa, Eating Disorders
- Being tested
- Erythromycin, Placebo
- Keywords
- Binge-Eating Disorder
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Also called E-mycin, Eryc, Ery-tab
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
PlaceboDrug
Also called inactive substance
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Experimental | Subjects with Bulimia Nervosa will take erythromycin. Receives: Drug: Erythromycin |
| Placebo | Placebo comparator | Participants will take matched placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 7
Percent of Meal Remaining/Minute
percent of meal remaining/minute
Measured: Measured at Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startSep 2004
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, B. Timothy Walsh, New York State Psychiatric Institute
- Investigators
- B. T. Walsh, MD, Principal investigator, New York State Psychiatric Institute at Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304187
- Sponsor's protocol ID
- #4902
- Other IDs
- R01MH042206-05, DATR A2-AID
- Status last verified
- Jun 2018
- First submitted
- 15 Mar 2006
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT00304187
- Acronym / sponsor ID
- #4902
- Conditions
- Bulimia Nervosa, Eating Disorders
- Keywords
- Binge-Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 30 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Experimental | Drug: ErythromycinSubjects with Bulimia Nervosa will take erythromycin. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take matched placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets criteria for bulimia nervosa
- Duration of illness is greater than 1 year
- Self-induces vomiting
- Weighs 80%-120 % of ideal weight
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythromycinAlso: E-mycin, Eryc, Ery-tabErythromycin, 250 mg or 500 mg, three times a day for 6 weeks | Drug | Erythromycin |
| PlaceboAlso: inactive substancePlacebo, 250 mg or 500 mg, three times a day for 6 weeks | Drug | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B. T. Walsh, MD principal investigator
New York State Psychiatric Institute at Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erythromycin in people with Bulimia Nervosa and Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Frequency (time frame: Measured at Week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.