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Central Nervous System Stimulant

Lisdexamfetamine for Binge Eating Disorder

Phase 2
Waitlist Available
Led By Susan L McEroy, MD
Research Sponsored by Lindner Center of HOPE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 3, 4, 6, 8, 10, 12
Awards & highlights

Study Summary

The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder

Eligible Conditions
  • Binge Eating Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 6, 8, 10, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 6, 8, 10, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Secondary outcome measures
Binge Eating Scale (BES)
Clinical Global Impression Improvement Scale (CGI-I)
Weight
+1 more

Side effects data

From 2022 Phase 4 trial • 69 Patients • NCT03187353
5%
Jitters
3%
Change in Appetite
3%
Dry Mouth
3%
Nausea
2%
Difficulty falling or staying asleep
2%
Dizziness/Disorientation
2%
Soreness/Tingling Skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lisdexamfetamine, 40 mg
Lisdexamfetamine, 60 mg
Lisdexamfetamine, 20 mg
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: LisdexamfetamineExperimental Treatment1 Intervention
During the Treatment Phase, subjects will be evaluated after 1, 2, 3, 4, 6, 8, 10, and 12 weeks (see Figure 2). The morning after completing the first fMRI scan, LDX will be started at 30 mg q AM (Baseline). After 1 week, LDX will then be increased to 50 mg q AM (Visit 1); after another week, LDX will be increased to 70 mg q AM (Visit 2). A single downward dose titration to 50 mg is allowed during week 3 if 70 mg/d is not tolerated. LDX dose at week 4 (50 or 70 mg/d) will be maintained for the next 8 weeks. Patients who do not tolerate 50 or 70 mg/day will be terminated. For patients who complete the 12-week treatment phase, LDX will be stopped at week 12 visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lisdexamfetamine
FDA approved

Find a Location

Who is running the clinical trial?

Lindner Center of HOPELead Sponsor
28 Previous Clinical Trials
1,355 Total Patients Enrolled
University of CincinnatiOTHER
428 Previous Clinical Trials
634,354 Total Patients Enrolled
Susan L McEroy, MDPrincipal InvestigatorLindner Center of HOPE

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects
2015. "Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02659488.
All > Binge Eating Disorder > Binge Eating
~4 spots leftby May 2025
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