A Study Examining the Effectiveness of an FDA-Approved Medication for the Treatment of Binge Eating Disorder
Brief Description Of Study
The 17-week, double-blind, randomized placebo-controlled trial will test the efficacy of an FDA-approved medication, liraglutide 3.0 mg/d, as compared to placebo in reducing the number of binge episodes per week, achieving remission from binge episodes, and in changes in body weight, global BED symptom improvement, and other psychological factors related to binge eating.
Detailed Study Description
Persons who are interested in the study will first complete a pre-screen electronically or over the phone to initially assess eligibiliy requirements. If they appear to be eligible after the initial screening, they will be invited to attend a behavioral screening visit. At the screening visit they will meet with a psychologist (or other qualified staff member) who will obtain informed consent, assess behavioral eligibility, BED symptoms, mood, and possible psychiatric illness. Additionally, participants will undergo a complete medical history and physical examination, EKG, and blood draws. Upon successful completion of the screening visit, there will be a 2-week run-in period where participants will be asked to report the number of binge episodes over that time. After the 2 week run-in period, the principal investigator will review all materials and further assess eligibility criteria based on the information gathered up to this point. If participants meet all eligibility criteria assessed at the screening visit and during the 2 week run-in period, they will be scheduled for a randomization screening visit where weight, blood pressure, and pulse will be measured. They will then be randomly assigned by chance to one of the two intervention groups (i.e., liraglutide 3.0 mg/day or placebo). After randomization, participants will return at week 1 to assess eating behavior and effects of the medication. Participants will the return for study visits every two weeks thereafter, at weeks 3, 5, 7, 9, 11, 13, 15, and 17. At these visits, there will be brief (5-10 minutes) medical visits with a physician or nurse practitioner (total of 9 visits), weight and vital signs (blood pressure and pulse) will be measured, and response to the treatment will be assessed. At these visits, participants will also meet with the study staff to assess binge eating episodes, mood, and psychological factors as assessed by clinical interviews and questionnaires. The final visit, week 17 will include all of the above in addition to the blood draw from baseline.