Vortioxetine for Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

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 description: 
      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 serotonin than the brain itself.
      Peripheral signals from the body (including from the intestinal tract, but also from the
      blood stream - e.g. glucose levels) are transmitted to brain regions such as the hypothalamic
      nuclei to help regulate appetite/hunger and maintain equilibrium. Another key aspect of
      circuitry involved in eating involves the brain reward system, including the nucleus
      accumbens, which is regulated by neurotransmitters such as dopamine, opioids, noradrenaline,
      and serotonin. In humans, but to a lesser degree in other animals, there is also top-down
      control from the prefrontal cortices, which serve to regulate our behaviors and suppress our
      tendencies to crave rewards, and allow us to flexibly adapt our behavior rather than get
      stuck in repetitive habits. Thus, binge-eating most likely involves dysregulation of all
      three above domains regulating behavior: the primitive 'peripheral-hypothalamic' feedback
      system, reward circuitry, and top-down control circuitry. On a neurochemical level, binge
      eating may be related to dysfunction of the serotonergic, dopamine, glutamatergic, and
      norepinephrine systems. Thus, a medication to target binge eating needs to be multi-modal in
      terms of its pharmacology.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Medication currently approved for major depression.
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment