Trial · NCT02528409

Vortioxetine for Binge Eating Disorder

NCT02528409, Phase 2, Completed, University of Chicago; results first posted 2020-05-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vortioxetine for Binge Eating Disorder. Trials, record NCT02528409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02528409

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vortioxetine for Binge Eating Disorder
NCT number: NCT02528409
Status: Completed
Phases: Phase 2
Enrollment: 80 participants, actual
Lead sponsor: University of Chicago
Conditions: Binge Eating Disorder
Interventions: Vortioxetine, Placebo
First posted: 2015-08-19
Last updated: 2020-11-23
Results first posted: 2020-05-01

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Number of Binge Eating Episodes	12 weeks	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).
Secondary	BMI	12 weeks	Assessment of change in patient body mass index over the course of the study (from baseline to the final visit at Week 12).
Secondary	Number of Participants With 4-week Cessation From Binge Eating	4 weeks	Subjects will be assessed at 4 weeks to determine cessation of binge eating status.
Secondary	Clinical Global Impression Improvement Scale (CGI)	Week 12 (final) visit	Patient global improvement relative to baseline, with scores ranging from 1-7. Higher scores indicate the patient is doing severely worse than they were at the beginning of treatment.
Secondary	Three-Factor Eating Questionnaire	12 weeks	A self-reported measure of binge eating behavior that will be collected at all 9 study visits with scores ranging from 0-51, with higher scores indicating more compulsive eating habits.
Secondary	Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating	12 weeks	A clinician-administered scale assessing binge eating severity that will be assessed at all 9 study visits. Scores range from 0-40 with higher scores indicating more severe OCD symptoms.
Secondary	Quality of Life Inventory	12 weeks	A self-report assessment of patient perceived quality of life that will be assessed at baseline and final visit. The scale provides a discrete score ranging from -192 to 192, with higher numbers indicating higher subjective quality of life.
Secondary	Hamilton Depression Rating Scale	12 weeks	A clinician-administered assessment of depression that will be assessed at all 8 study visits after the baseline visit. The scale provides a discrete score that ranges from 0-52, with higher scores indicating more severe depressive symptoms.
Secondary	Hamilton Anxiety Rating Scale	12 weeks	A clinician-administered assessment of anxiety that will be assessed at all 9 study visits. The scale provides a discrete score that ranges from 0-56, with higher scores indicating more severe anxiety symptoms.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Number of Binge Eating Episodes	12 weeks	binge eating episodes	MEAN
SECONDARY	BMI	12 weeks	kg/m^2	MEAN
SECONDARY	Number of Participants With 4-week Cessation From Binge Eating	4 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Global Impression Improvement Scale (CGI)	Week 12 (final) visit	units on a scale	MEAN
SECONDARY	Three-Factor Eating Questionnaire	12 weeks	units on a scale	MEAN
SECONDARY	Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating	12 weeks	units on a scale	MEAN
SECONDARY	Quality of Life Inventory	12 weeks	units on a scale	MEAN
SECONDARY	Hamilton Depression Rating Scale	12 weeks	units on a scale	MEAN
SECONDARY	Hamilton Anxiety Rating Scale	12 weeks	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Number of Binge Eating Episodes	Placebo		.93	Standard Deviation 1.49	binge eating episodes
Change in Number of Binge Eating Episodes	Vortioxetine		.76	Standard Deviation 1.33	binge eating episodes
BMI	Placebo	Pre-Treatment	36.19	Standard Deviation 8.47	kg/m^2
BMI	Vortioxetine	Pre-Treatment	38.39	Standard Deviation 9.30	kg/m^2
BMI	Placebo	Post-Treatment	36.29	Standard Deviation 8.52	kg/m^2
BMI	Vortioxetine	Post-Treatment	38.73	Standard Deviation 9.66	kg/m^2
Number of Participants With 4-week Cessation From Binge Eating	Placebo	No 4-Week Cessation	27		Participants
Number of Participants With 4-week Cessation From Binge Eating	Vortioxetine	No 4-Week Cessation	26		Participants
Number of Participants With 4-week Cessation From Binge Eating	Placebo	4-Week Cessation	10		Participants
Number of Participants With 4-week Cessation From Binge Eating	Vortioxetine	4-Week Cessation	13		Participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	40
Overall Study	STARTED	Vortioxetine	40
Overall Study	COMPLETED	Placebo	18
Overall Study	COMPLETED	Vortioxetine	24
Overall Study	NOT COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	Vortioxetine	16

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Itching	Skin and subcutaneous tissue disorders	Placebo	1	40	1
other	Itching	Skin and subcutaneous tissue disorders	Vortioxetine	2	40	2
other	Nausea	Gastrointestinal disorders	Placebo	6	40	9
other	Nausea	Gastrointestinal disorders	Vortioxetine	10	40	20
other	Headache	Nervous system disorders	Placebo	4	40	5
other	Headache	Nervous system disorders	Vortioxetine	4	40	4
other	Dizziness	Nervous system disorders	Placebo	3	40	5
other	Dizziness	Nervous system disorders	Vortioxetine	4	40	4
other	Dry Mouth	Gastrointestinal disorders	Placebo	2	40	5
other	Dry Mouth	Gastrointestinal disorders	Vortioxetine	4	40	5

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	40
Total, all-cause mortality	Vortioxetine	0	40
Total, other adverse events	Placebo	18	40
Total, other adverse events	Vortioxetine	20	40
Total, serious adverse events	Placebo	0	40
Total, serious adverse events	Vortioxetine	0	40

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
13638508	BACKGROUND	PubMed
14399272	BACKGROUND	PubMed
16815322	BACKGROUND	PubMed
17258690	BACKGROUND	PubMed
19282821	BACKGROUND	PubMed
19501749	BACKGROUND	PubMed
20141625	BACKGROUND	PubMed
20348917	BACKGROUND	PubMed
22654518	BACKGROUND	PubMed
23290497	BACKGROUND	PubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vortioxetine vs Placebo: deaths from any cause	Trial comparisons
Vortioxetine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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