Trial · NCT03924193

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

NCT03924193, Phase 3, Completed, Yale University; results first posted 2024-10-17

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: Acute Treatment. Trials, record NCT03924193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03924193

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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: Acute Treatment
NCT number: NCT03924193
Status: Completed
Phases: Phase 3
Enrollment: 141 participants, actual
Lead sponsor: Yale University
Conditions: Binge-Eating Disorder, Obesity
Interventions: Lisdexamfetamine Dimesylate, Cognitive-Behavioral Therapy, Combination LDX and Cognitive-Behavioral Therapy
First posted: 2019-04-23
Last updated: 2024-10-17
Results first posted: 2024-10-17

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Binge-Eating Frequency	Post-treatment (3 months)	Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Primary	Body Mass Index	Post-treatment (3 months)	BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain.
Secondary	Binge-Eating Remission	Post-treatment (3 months)	Categorical: zero binges/28 days
Secondary	Eating-Disorder Psychopathology	Post-treatment (3 months)	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	Depressive Symptoms	Post-treatment (3 months)	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).

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Binge-Eating Frequency	Post-treatment (3 months)	Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.	Binge-eating episodes (past 28 days)	MEAN
PRIMARY	Body Mass Index	Post-treatment (3 months)	Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.	percentage of change in weight	MEAN
SECONDARY	Binge-Eating Remission	Post-treatment (3 months)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Eating-Disorder Psychopathology	Post-treatment (3 months)	Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.	scores on a scale ranging from 0-6	MEAN
SECONDARY	Depressive Symptoms	Post-treatment (3 months)	Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.	scores on a scale ranging from 0-63	MEAN

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Binge-Eating Frequency	Lisdexamfetamine Dimesylate (LDX)	2.95	Standard Deviation 6.04	Binge-eating episodes (past 28 days)
Binge-Eating Frequency	Cognitive-Behavioral Therapy	2.33	Standard Deviation 5.88	Binge-eating episodes (past 28 days)
Binge-Eating Frequency	LDX and Cognitive Behavioral Therapy	0.96	Standard Deviation 2.67	Binge-eating episodes (past 28 days)
Body Mass Index	Lisdexamfetamine Dimesylate (LDX):	-5.49	Standard Deviation 3.47	percentage of change in weight
Body Mass Index	Cognitive-Behavioral Therapy	-0.50	Standard Deviation 2.70	percentage of change in weight
Body Mass Index	LDX and Cognitive Behavioral Therapy	-4.76	Standard Deviation 3.57	percentage of change in weight
Binge-Eating Remission	Lisdexamfetamine Dimesylate (LDX)	19		Participants
Binge-Eating Remission	Cognitive-Behavioral Therapy	21		Participants
Binge-Eating Remission	LDX and Cognitive Behavioral Therapy	33		Participants
Eating-Disorder Psychopathology	Lisdexamfetamine Dimesylate (LDX)	1.62	Standard Deviation 0.94	scores on a scale ranging from 0-6

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Dimesylate (LDX)	47
Overall Study	STARTED	Cognitive-Behavioral Therapy	47
Overall Study	STARTED	LDX and Cognitive Behavioral Therapy	47
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate (LDX)	32
Overall Study	COMPLETED	Cognitive-Behavioral Therapy	37
Overall Study	COMPLETED	LDX and Cognitive Behavioral Therapy	35
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate (LDX)	15
Overall Study	NOT COMPLETED	Cognitive-Behavioral Therapy	10
Overall Study	NOT COMPLETED	LDX and Cognitive Behavioral Therapy	12

Source ClinicalTrials.gov

Adverse events51

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	Lisdexamfetamine Dimesylate (LDX)	42	47
other	Decreased appetite	Gastrointestinal disorders	Cognitive-Behavioral Therapy		0
other	Decreased appetite	Gastrointestinal disorders	LDX and Cognitive Behavioral Therapy	35	47
other	Dry Mouth	General disorders	Lisdexamfetamine Dimesylate (LDX)	28	47
other	Dry Mouth	General disorders	Cognitive-Behavioral Therapy		0
other	Dry Mouth	General disorders	LDX and Cognitive Behavioral Therapy	26	47
other	Increased Energy	General disorders	Lisdexamfetamine Dimesylate (LDX)	26	47
other	Increased Energy	General disorders	Cognitive-Behavioral Therapy		0
other	Increased Energy	General disorders	LDX and Cognitive Behavioral Therapy	25	47
other	Feeling Jittery	General disorders	Lisdexamfetamine Dimesylate (LDX)	18	47

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Dimesylate (LDX)	0	47
Total, all-cause mortality	Cognitive-Behavioral Therapy	0	47
Total, all-cause mortality	LDX and Cognitive Behavioral Therapy	0	47
Total, other adverse events	Lisdexamfetamine Dimesylate (LDX)	46	47
Total, other adverse events	Cognitive-Behavioral Therapy	0	0
Total, other adverse events	LDX and Cognitive Behavioral Therapy	46	47
Total, serious adverse events	Lisdexamfetamine Dimesylate (LDX)	1	47
Total, serious adverse events	Cognitive-Behavioral Therapy	0	47
Total, serious adverse events	LDX and Cognitive Behavioral Therapy	0	47

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40338285	DERIVED	PubMed
40631364	DERIVED	PubMed
42057441	DERIVED	PubMed

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 comparisons0

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

None in this release.

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/NCT03924193

GET https://conductscience.org/api/trials/v1/NCT03924193/events?page=2

API reference For AI assistants