Clinical Trial: Vortioxetine for Binge Eating Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled Study of Vortioxetine in the Treatment of Binge Eating Disorder

Brief 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.

Detailed Summary:

Binge-eating disorder recently included in the Diagnostic and Statistical Manual, 5th Edition, is now recognized as a serious public health problem. Binge-eating disorder is associated with obesity and psychiatric comorbidities, including depression, and may be predictive of metabolic syndrome. Many patients are undertreated despite functional impairments and personal and social difficulties leading to a poor quality of life. Binge-eating disorder is characterized by recurrent episodes of excessive food consumption accompanied by a sense of loss of control and psychological distress but without the inappropriate compensatory weight-loss behaviors of bulimia nervosa. Binge eating is seen in 23-46% of obese individuals seeking weight loss treatment and its severity relates to body mass index and predicts regain of lost weight.

Current treatments for binge eating disorder are often inadequate. Cognitive behavioral therapy has been shown to reduce binge eating but finding trained psychologists is difficult. Lisdexamfetamine was recently approved by the Food and Drug Administration for binge eating disorder but it carries risk of addiction and diversion and so will likely not be prescribed by most family physicians or psychiatrists. Other currently available medications, used off-label for binge eating disorder, include anticonvulsants, which may reduce binge eating but are often poorly tolerated. Therefore, additional clinical trials are needed to identify effective pharmacotherapies.

Consuming food is necessary for life and involves brain regions that are quite ancient in evolutionary terms. The intestinal tract itself is almost like a "second brain" in that it contains vast amounts of neurons used to transmit and process sensory information; indeed the intestinal tract contains more of the neurotransmitter serotoni
Sponsor: University of Chicago

Current Primary Outcome: Number of binge eating episode [ Time Frame: 12 weeks ]

Subjects will report the number of binge eating episodes since the last visit both to the investigator and via daily eating journals at all 9 visits.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • BMI [ Time Frame: 12 weeks ]
    Assessment of change in patient body mass index over the course of the study, assessed at all 9 visits.
  • Assessed 4-week cessation from Binge eating [ Time Frame: 4 weeks ]
    Subjects will be assessed at 4 weeks to determine cessation of binge eating status.
  • Clinical Global Impression Improvement Scale (CGI) [ Time Frame: 12 weeks ]
    After the first visit, rater will assess patient improvement relative to baseline on the CGI.
  • Three-Factor Eating Questionnaire [ Time Frame: 12 weeks ]
    A self-reported measure of binge eating behavior that will be collected at all 9 study visits.
  • Yale-Brown Obsessive Compulsive Scale modified for Binge Eating [ Time Frame: 12 weeks ]
    A clinician-administered scale assessing binge eating severity that will be assessed at all 9 study visits.
  • Barratt Impulsiveness Scale [ Time Frame: 12 weeks ]
    A self-report assessment of impulsivity that will be assessed at baseline and final visit.
  • Quality of Life Inventory [ Time Frame: 12 weeks ]
    A self-report assessment of patient perceived quality of life that will be assessed at baseline and final visit.
  • Hamilton Depression Rating Scale [ Time Frame: 12 weeks ]
    A clinician-administered assessment of depression that will be assessed at all 9 study visits.
  • Hamilton Anxiety Rating Scale [ Time Frame: 12 weeks ]
    A clinician-administered assessment of anxiety that will be assessed at all 9 study visits.


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: August 13, 2015
Date Started: June 2016
Date Completion: October 2018
Last Updated: January 9, 2017
Last Verified: January 2017