Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2016-06-30
2018-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo
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.
Vortioxetine
Medication currently approved for major depression.
Interventions
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Vortioxetine
Medication currently approved for major depression.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Jon E Grant, JD, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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References
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Davis CA, Levitan RD, Reid C, Carter JC, Kaplan AS, Patte KA, King N, Curtis C, Kennedy JL. Dopamine for "wanting" and opioids for "liking": a comparison of obese adults with and without binge eating. Obesity (Silver Spring). 2009 Jun;17(6):1220-5. doi: 10.1038/oby.2009.52. Epub 2009 Mar 12.
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.
Gibb A, Deeks ED. Vortioxetine: first global approval. Drugs. 2014 Jan;74(1):135-45. doi: 10.1007/s40265-013-0161-9.
HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3.
Johnson PM, Kenny PJ. Dopamine D2 receptors in addiction-like reward dysfunction and compulsive eating in obese rats. Nat Neurosci. 2010 May;13(5):635-41. doi: 10.1038/nn.2519. Epub 2010 Mar 28.
Kessler RC, Berglund PA, Chiu WT, Deitz AC, Hudson JI, Shahly V, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Benjet C, Bruffaerts R, de Girolamo G, de Graaf R, Maria Haro J, Kovess-Masfety V, O'Neill S, Posada-Villa J, Sasu C, Scott K, Viana MC, Xavier M. The prevalence and correlates of binge eating disorder in the World Health Organization World Mental Health Surveys. Biol Psychiatry. 2013 May 1;73(9):904-14. doi: 10.1016/j.biopsych.2012.11.020. Epub 2013 Jan 3.
Latagliata EC, Patrono E, Puglisi-Allegra S, Ventura R. Food seeking in spite of harmful consequences is under prefrontal cortical noradrenergic control. BMC Neurosci. 2010 Feb 8;11:15. doi: 10.1186/1471-2202-11-15.
Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RS. A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, Flexible-Dose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder. Neuropsychopharmacology. 2015 Jul;40(8):2025-37. doi: 10.1038/npp.2015.52. Epub 2015 Feb 17.
Mathes WF, Brownley KA, Mo X, Bulik CM. The biology of binge eating. Appetite. 2009 Jun;52(3):545-553. doi: 10.1016/j.appet.2009.03.005. Epub 2009 Mar 20.
McElroy SL, Hudson JI, Capece JA, Beyers K, Fisher AC, Rosenthal NR; Topiramate Binge Eating Disorder Research Group. Topiramate for the treatment of binge eating disorder associated with obesity: a placebo-controlled study. Biol Psychiatry. 2007 May 1;61(9):1039-48. doi: 10.1016/j.biopsych.2006.08.008. Epub 2007 Jan 29.
McElroy SL, Guerdjikova AI, Mori N, O'Melia AM. Pharmacological management of binge eating disorder: current and emerging treatment options. Ther Clin Risk Manag. 2012;8:219-41. doi: 10.2147/TCRM.S25574. Epub 2012 May 8.
McElroy SL, Hudson JI, Mitchell JE, Wilfley D, Ferreira-Cornwell MC, Gao J, Wang J, Whitaker T, Jonas J, Gasior M. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):235-46. doi: 10.1001/jamapsychiatry.2014.2162.
Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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15-1115
Identifier Type: -
Identifier Source: org_study_id