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Trial record 8 of 594 for:    binge eating disorder

Vortioxetine for Binge Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02528409
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: Vortioxetine Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Vortioxetine in the Treatment of Binge Eating Disorder
Study Start Date : June 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Placebo Comparator: Placebo
10 milligrams per day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.
Drug: Placebo
Experimental: Vortioxetine
10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.
Drug: Vortioxetine
Medication currently approved for major depression.
Other Name: Brintellix




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. BMI [ Time Frame: 12 weeks ]
    Assessment of change in patient body mass index over the course of the study, assessed at all 9 visits.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Barratt Impulsiveness Scale [ Time Frame: 12 weeks ]
    A self-report assessment of impulsivity that will be assessed at baseline and final visit.

  7. 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.

  8. Hamilton Depression Rating Scale [ Time Frame: 12 weeks ]
    A clinician-administered assessment of depression that will be assessed at all 9 study visits.

  9. Hamilton Anxiety Rating Scale [ Time Frame: 12 weeks ]
    A clinician-administered assessment of anxiety that will be assessed at all 9 study visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528409


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Takeda
Investigators
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Chicago

Publications:
Frisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess 4:92-101.
Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02528409     History of Changes
Other Study ID Numbers: 15-1115
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Pathologic Processes
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists