NCT02528409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 1, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

August 13, 2015

Results QC Date

July 8, 2019

Last Update Submit

November 19, 2020

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Binge Eating Episodes

    Subjects will report the number of binge eating episodes in the week preceding the final visit (Week 12 of treatment), both to the investigator and via daily eating journals at all 9 visits. The outcome measure was the change in number of episodes from Week 0 (baseline) to the final visit (Week 12).

    12 weeks

Secondary Outcomes (8)

  • BMI

    12 weeks

  • Number of Participants With 4-week Cessation From Binge Eating

    4 weeks

  • Clinical Global Impression Improvement Scale (CGI)

    Week 12 (final) visit

  • Three-Factor Eating Questionnaire

    12 weeks

  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Vortioxetine

EXPERIMENTAL

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

Interventions

VortioxetineDRUG

Medication currently approved for major depression.

Also known as: Brintellix
Vortioxetine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women age 18-65;
  • Primary diagnosis of Binge eating disorder;
  • At least 3 binge eating days per week for the 2 weeks before the baseline visit;
  • Ability to understand and sign the consent form.

You may not qualify if:

  • 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)
  • Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  • Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
  • Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder, major depressive disorder)
  • Past 6-month alcohol or substance use disorders
  • Illegal substance use based on urine toxicology screening
  • Initiation of psychological or weight-loss interventions within 3 months of screening
  • Use of any other prescription psychotropic medication (except an as needed hypnotic or as needed benzodiazepine)
  • Previous treatment with Vortioxetine
  • Currently taking over the counter weight loss medications. If willing to stop these medications, the participant will not be excluded based on this criterion.
  • \) Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (15)

  • 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.

    PMID: 19282821BACKGROUND

  • 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.

    BACKGROUND

  • Gibb A, Deeks ED. Vortioxetine: first global approval. Drugs. 2014 Jan;74(1):135-45. doi: 10.1007/s40265-013-0161-9.

    PMID: 24311349BACKGROUND

  • 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.

    PMID: 13638508BACKGROUND

  • 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.

    PMID: 14399272BACKGROUND

  • 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.

    PMID: 16815322BACKGROUND

  • 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.

    PMID: 20348917BACKGROUND

  • 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.

    PMID: 23290497BACKGROUND

  • 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.

    PMID: 20141625BACKGROUND

  • 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.

    PMID: 25687662BACKGROUND

  • 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.

    PMID: 19501749BACKGROUND

  • 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.

    PMID: 17258690BACKGROUND

  • 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.

    PMID: 22654518BACKGROUND

  • 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.

    PMID: 25587645BACKGROUND

  • Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.

    BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Jon E. Grant
Organization
University of Chicago
jongrant@uchicago.edu
773-834-1325

Study Officials

  • Jon E Grant, JD, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 19, 2015

Study Start

June 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 23, 2020

Results First Posted

May 1, 2020

Record last verified: 2020-11

Locations

US(1)