LDX for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Obesity+1 MoreCombination LDX and Cognitive-Behavioral Therapy - Other
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of cognitive behavioral therapy, lisdexamfetamine, and a combination of the two for treating binge-eating disorder in obese patients.

Eligible Conditions
  • Obesity
  • Binge Eating Disorder

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Post-treatment (3 months)

Post-treatment (3 months)
Binge-Eating Frequency
Binge-Eating Remission
Body Mass Index
Depressive Symptoms
Eating-Disorder Psychopathology

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

LDX
1 of 3
Cognitive-Behavioral Therapy
1 of 3
LDX and Cognitive Behavioral Therapy
1 of 3

Active Control

180 Total Participants · 3 Treatment Groups

Primary Treatment: LDX · No Placebo Group · Phase 3

LDX
Drug
ActiveComparator Group · 1 Intervention: Lisdexamfetamine Dimesylate · Intervention Types: Drug
Cognitive-Behavioral Therapy
Behavioral
ActiveComparator Group · 1 Intervention: Cognitive-Behavioral Therapy · Intervention Types: Behavioral
LDX and Cognitive Behavioral Therapy
Other
ActiveComparator Group · 1 Intervention: Combination LDX and Cognitive-Behavioral Therapy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post-treatment (3 months)

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,680 Previous Clinical Trials
21,088,079 Total Patients Enrolled
58 Trials studying Obesity
248,012 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,149 Previous Clinical Trials
4,074,629 Total Patients Enrolled
404 Trials studying Obesity
492,865 Patients Enrolled for Obesity
Carlos M Grilo, Ph.D.Principal InvestigatorYale University
4 Previous Clinical Trials
282 Total Patients Enrolled
2 Trials studying Obesity
120 Patients Enrolled for Obesity

Eligibility Criteria

Age 18 - 64 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to travel to the study location (New Haven, CT) for weekly visits.
You are medically cleared.
You are able to read, comprehend, and write English at a sufficient level to complete study-related materials.