Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT01098435
Eligibility Criteria:
Inclusion Criteria:
* Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)
* Display greater than or equal to 3 binge eating days per week
* Body mass index (BMI) greater than or equal to 30 kg/m2
* Age of 18 years or older
* Women of childbearing potential must agree to use an approved method of birth control for the duration of the study
Exclusion Criteria:
* Concurrent symptoms of bulimia nervosa or anorexia nervosa
* Suicidal ideation
* DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
* Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
* Women who are pregnant or breastfeeding
* Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
* Clinically unstable medical disease
* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* History of seizures, including clinically significant febrile seizures in childhood
* Current or anticipated need for prescribed opioid medication during the study period
* Use of any psychotropic medications (other than hypnotics)
* Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01098435
Study Brief:
Protocol Section:
NCT01098435