Phase 2
N=80
Vortioxetine for Binge Eating Disorder
Binge Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02528409 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change in Number of Binge Eating Episodes — .93; .76 binge eating episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vortioxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Binge Eating Episodes |
.93; .76 | — |
| SECONDARY BMI |
36.19; 38.39; 36.29; 38.73 | — |
| SECONDARY Number of Participants With 4-week Cessation From Binge Eating |
27; 26; 10; 13 | — |
| SECONDARY Clinical Global Impression Improvement Scale (CGI) |
4.18; 4.25; 2.79; 2.70 | — |
| SECONDARY Three-Factor Eating Questionnaire |
7.71; 6.92; 9.85; 9.48 | — |
| SECONDARY Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating |
20.10; 20.55; 10.44; 9.94 | — |
| SECONDARY Quality of Life Inventory |
39.13; 35.00; 46.22; 44.00 | — |
| SECONDARY Hamilton Depression Rating Scale |
4.55; 4.32; 2.06; 3.66 | — |
| SECONDARY Hamilton Anxiety Rating Scale |
4.13; 3.68; 1.79; 2.72 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02528409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.