Vortioxetine for Binge Eating Disorder

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Takeda
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. Men and women age 18-65;

2. Primary diagnosis of Binge eating disorder;

3. At least 3 binge eating days per week for the 2 weeks before the baseline visit;

4. Ability to understand and sign the consent form.

Exclusion Criteria:

1. 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)

2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential

3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

4. Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder, major depressive disorder)

5. Past 6-month alcohol or substance use disorders

6. Illegal substance use based on urine toxicology screening

7. Initiation of psychological or weight-loss interventions within 3 months of screening

8. Use of any other prescription psychotropic medication (except an as needed hypnotic or as needed benzodiazepine)

9. Previous treatment with Vortioxetine

10. Currently taking over the counter weight loss medications. If willing to stop these medications, the participant will not be excluded based on this criterion.

10) Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent