Trial · NCT03926052

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment

NCT03926052, Phase 3, Completed, Yale University; results first posted 2025-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment. Trials, record NCT03926052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03926052

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Trial

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

Title: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment
NCT number: NCT03926052
Status: Completed
Phases: Phase 3
Enrollment: 61 participants, actual
Lead sponsor: Yale University
Conditions: Binge-Eating Disorder, Obesity
Interventions: Lisdexamfetamine Dimesylate, Placebo
First posted: 2019-04-24
Last updated: 2025-12-17
Results first posted: 2025-12-17

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Binge-Eating Relapse	12 weeks	Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Primary	Binge-Eating Relapse	6-month follow-up	Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Primary	Binge-Eating Relapse	12 month follow-up	Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
Secondary	Change in Binge-Eating Frequency	From baseline interview at study enrollment to 3 months after the 12-week treatment	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Secondary	Change in Binge-Eating Frequency	From post-treatment to the 6-month follow-up	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Secondary	Change in Binge-Eating Frequency	From post-treatment to the 12-month follow-up	Binge-eating frequency is a continuous variable of binge-eating episodes assessed using the Eating Disorder Examination interview; Binge-eating frequency will be based on the past 28 days and defined as binge-eating episodes per month.
Secondary	Change in Eating-Disorder Psychopathology (Continuous)	From baseline interview at study enrollment to 3 months after the 12-week treatment	Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Secondary	Change in Eating-Disorder Psychopathology (Continuous)	From post-treatment to the 6-month follow-up	Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Secondary	Change in Eating-Disorder Psychopathology (Continuous)	From post-treatment to the 12-month follow-up	Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Secondary	Change in Depressive Symptoms	From baseline interview at study enrollment to 3 months after the 12-week treatment	Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Binge-Eating Relapse	12 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Binge-Eating Relapse	6-month follow-up	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Binge-Eating Relapse	12 month follow-up	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Binge-Eating Frequency	From baseline interview at study enrollment to 3 months after the 12-week treatment	episodes per the past 28 days	MEAN
SECONDARY	Change in Binge-Eating Frequency	From post-treatment to the 6-month follow-up	episodes per the past 28 days	MEAN
SECONDARY	Change in Binge-Eating Frequency	From post-treatment to the 12-month follow-up	episodes per the past 28 days	MEAN
SECONDARY	Change in Eating-Disorder Psychopathology (Continuous)	From baseline interview at study enrollment to 3 months after the 12-week treatment	score on a scale	MEAN
SECONDARY	Change in Eating-Disorder Psychopathology (Continuous)	From post-treatment to the 6-month follow-up	score on a scale	MEAN
SECONDARY	Change in Eating-Disorder Psychopathology (Continuous)	From post-treatment to the 12-month follow-up	score on a scale	MEAN
SECONDARY	Change in Depressive Symptoms	From baseline interview at study enrollment to 3 months after the 12-week treatment	score on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group30

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

Outcome	Group	Value	Spread	Units
Binge-Eating Relapse	LDX (Lisdexamfetamine Dimesylate)	3		Participants
Binge-Eating Relapse	Placebo	5		Participants
Binge-Eating Relapse	LDX (Lisdexamfetamine Dimesylate)	6		Participants
Binge-Eating Relapse	Placebo	6		Participants
Binge-Eating Relapse	LDX (Lisdexamfetamine Dimesylate)	3		Participants
Binge-Eating Relapse	Placebo	2		Participants
Change in Binge-Eating Frequency	LDX (Lisdexamfetamine Dimesylate)	1.33	Standard Deviation 5.82	episodes per the past 28 days
Change in Binge-Eating Frequency	Placebo	1.61	Standard Deviation 4.37	episodes per the past 28 days
Change in Binge-Eating Frequency	LDX (Lisdexamfetamine Dimesylate)	2.45	Standard Deviation 5.39	episodes per the past 28 days
Change in Binge-Eating Frequency	Placebo	1.00	Standard Deviation 6.86	episodes per the past 28 days

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LDX (Lisdexamfetamine Dimesylate)	32
Overall Study	STARTED	Placebo	29
Overall Study	COMPLETED	LDX (Lisdexamfetamine Dimesylate)	30
Overall Study	COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	LDX (Lisdexamfetamine Dimesylate)	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events14

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
other	Decreased appetite	Gastrointestinal disorders	LDX (Lisdexamfetamine Dimesylate)	10	32
other	Decreased appetite	Gastrointestinal disorders	Placebo	4	29
other	Dry mouth	General disorders	LDX (Lisdexamfetamine Dimesylate)	6	32
other	Dry mouth	General disorders	Placebo	1	29
other	Insomnia	General disorders	LDX (Lisdexamfetamine Dimesylate)	6	32
other	Insomnia	General disorders	Placebo	4	29
other	Increased energy	General disorders	LDX (Lisdexamfetamine Dimesylate)	5	32
other	Increased energy	General disorders	Placebo	3	29
other	Constipation	Gastrointestinal disorders	LDX (Lisdexamfetamine Dimesylate)	3	32
other	Constipation	Gastrointestinal disorders	Placebo	1	29

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LDX (Lisdexamfetamine Dimesylate)	0	32
Total, all-cause mortality	Placebo	0	29
Total, other adverse events	LDX (Lisdexamfetamine Dimesylate)	13	32
Total, other adverse events	Placebo	6	29
Total, serious adverse events	LDX (Lisdexamfetamine Dimesylate)	0	32
Total, serious adverse events	Placebo	0	29

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK114075	Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder	GRILO, CARLOS M	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2018 to 2022

Source NIH RePORTER

Trial comparisons5

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

Comparison	Source
LDX (Lisdexamfetamine Dimesylate) vs Placebo: Binge-Eating Relapse	Trial comparisons
LDX (Lisdexamfetamine Dimesylate) vs Placebo: Binge-Eating Relapse	Trial comparisons
LDX (Lisdexamfetamine Dimesylate) vs Placebo: Binge-Eating Relapse	Trial comparisons
LDX (Lisdexamfetamine Dimesylate) vs Placebo: deaths from any cause	Trial comparisons
LDX (Lisdexamfetamine Dimesylate) 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.

GET https://conductscience.org/api/trials/v1/NCT03926052

GET https://conductscience.org/api/trials/v1/NCT03926052/results?page=2

API reference For AI assistants