Trial Outcomes & Findings for Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment (NCT NCT03926052)

NCT ID: NCT03926052

Last Updated: 2025-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 61 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-12-17

Participant Flow

Participant milestones

Measure	LDX (Lisdexamfetamine Dimesylate) Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Overall Study STARTED	32	29
Overall Study COMPLETED	30	28
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	LDX (Lisdexamfetamine Dimesylate) n=32 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=29 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.	Total n=61 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants
Age, Continuous	42.97 years STANDARD_DEVIATION 11.38 • n=6 Participants	45.83 years STANDARD_DEVIATION 10.24 • n=5 Participants	44.33 years STANDARD_DEVIATION 10.86 • n=5 Participants
Sex: Female, Male Female	27 Participants n=6 Participants	24 Participants n=5 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=6 Participants	5 Participants n=5 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=6 Participants	4 Participants n=5 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=6 Participants	25 Participants n=5 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=6 Participants	6 Participants n=5 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=6 Participants	21 Participants n=5 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=6 Participants	0 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=6 Participants	1 Participants n=5 Participants	3 Participants n=5 Participants
Region of Enrollment United States	32 participants n=6 Participants	29 participants n=5 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=30 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=28 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Relapse	3 Participants	5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=20 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=23 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Relapse	6 Participants	6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=18 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=23 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Binge-Eating Relapse	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=30 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=28 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	1.33 episodes per the past 28 days Standard Deviation 5.82	1.61 episodes per the past 28 days Standard Deviation 4.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=20 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=24 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	2.45 episodes per the past 28 days Standard Deviation 5.39	1.00 episodes per the past 28 days Standard Deviation 6.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=18 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=23 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Binge-Eating Frequency	1.28 episodes per the past 28 days Standard Deviation 4.14	-.09 episodes per the past 28 days Standard Deviation 2.29

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=28 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=27 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	-0.05 score on a scale Standard Deviation 0.77	0.50 score on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=19 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=22 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	0.23 score on a scale Standard Deviation 0.95	0.17 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=17 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=23 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Eating-Disorder Psychopathology (Continuous)	0.09 score on a scale Standard Deviation 0.83	-0.07 score on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=25 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=28 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	2.16 score on a scale Standard Deviation 5.27	0.18 score on a scale Standard Deviation 7.07

SECONDARY outcome

Timeframe: From post-treatment to the 6-month follow-up

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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=17 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=20 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	1.12 score on a scale Standard Deviation 5.63	3.35 score on a scale Standard Deviation 9.14

SECONDARY outcome

Timeframe: From post-treatment to the 12-month follow-up

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).

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=15 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=21 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Change in Depressive Symptoms	0.07 score on a scale Standard Deviation 6.98	1.71 score on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: From baseline interview at study enrollment to 3 months after the 12-week treatment

Negative values indicate weight loss and positive values indicate weight gain.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=30 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=28 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	-2.39 percent change Standard Deviation 2.95	2.25 percent change Standard Deviation 2.51

SECONDARY outcome

Timeframe: From post-treatment to the 6-month follow-up

Negative values indicate weight loss and positive values indicate weight gain.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=18 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=22 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	2.54 percent change Standard Deviation 6.32	0.45 percent change Standard Deviation 3.04

SECONDARY outcome

Timeframe: From post-treatment to the 12-month follow-up

Negative values indicate weight loss and positive values indicate weight gain.

Outcome measures

Measure	LDX (Lisdexamfetamine Dimesylate) n=17 Participants Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=23 Participants Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Percent Change in Weight	4.04 percent change Standard Deviation 6.58	2.67 percent change Standard Deviation 5.73

Adverse Events

LDX (Lisdexamfetamine Dimesylate)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LDX (Lisdexamfetamine Dimesylate) n=32 participants at risk Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.	Placebo n=29 participants at risk Placebo: Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Gastrointestinal disorders Decreased appetite	31.2% 10/32 • 12 weeks	13.8% 4/29 • 12 weeks
General disorders Dry mouth	18.8% 6/32 • 12 weeks	3.4% 1/29 • 12 weeks
General disorders Insomnia	18.8% 6/32 • 12 weeks	13.8% 4/29 • 12 weeks
General disorders Increased energy	15.6% 5/32 • 12 weeks	10.3% 3/29 • 12 weeks
Gastrointestinal disorders Constipation	9.4% 3/32 • 12 weeks	3.4% 1/29 • 12 weeks
General disorders Feeling jittery	6.2% 2/32 • 12 weeks	0.00% 0/29 • 12 weeks
Nervous system disorders Increased heart rate	6.2% 2/32 • 12 weeks	3.4% 1/29 • 12 weeks

Additional Information

Dr. Carlos Grilo

Yale University School of Medicine

Phone: 2037857210

Email: carlos.grilo@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place