Vortioxetine for Binge Eating Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Binge Eating Disorder
In brief
The aim of the present study is to examine the efficacy and safety of vortioxetine vs placebo in adults with moderate to severe Binge eating disorder, as indicated by at least 3 binge eating days per week for the 2 weeks before the baseline visit.
Key facts
- Study ID
- NCT02528409
- Run by
- University of Chicago
- People needed
- 80
- Starts
- 2016-06-01
- Expected to finish
- 2018-11-01
- Last updated by the study team
- 2020-11-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women age 18-65;
- Primary diagnosis of Binge eating disorder;
- At least 3 binge eating days per week for the 2 weeks before the baseline visit;
- Ability to understand and sign the consent form.
You may not qualify if…
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (history of medical illness which is currently stable is allowed such as diabetes well controlled, treated hypothyroidism, hypertension, etc)
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder, major depressive disorder)
- Past 6-month alcohol or substance use disorders
- Illegal substance use based on urine toxicology screening
- Initiation of psychological or weight-loss interventions within 3 months of screening
- Use of any other prescription psychotropic medication (except an as needed hypnotic or as needed benzodiazepine)
- Previous treatment with Vortioxetine
- Currently taking over the counter weight loss medications. If willing to stop these medications, the participant will not be excluded based on this criterion.
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Where it is running
- University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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