Vortioxetine for Binge Eating Disorder
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|ClinicalTrials.gov Identifier: NCT02528409|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Binge Eating Disorder||Drug: Vortioxetine Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
Medication currently approved for major depression.
Other Name: Brintellix
- 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.
- 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.
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
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Jon E Grant, JD, MD, MPH||University of Chicago|