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Central Nervous System Stimulant
Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects
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
No Placebo-Only Group
All Individual Drugs Already Approved
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1, 2, 3, 4, 6, 8, 10, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 6, 8, 10, 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Secondary study objectives
Binge Eating Scale (BES)
Clinical Global Impression Improvement Scale (CGI-I)
Weight
+1 moreSide effects data
From 2022 Phase 4 trial • 69 Patients • NCT031873532%
mild to moderate headache
2%
Increased blood pressure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lisdexamfetamine, 20 mg
Lisdexamfetamine, 40 mg
Placebo
Lisdexamfetamine, 60 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
438 Previous Clinical Trials
638,648 Total Patients Enrolled
Susan L McEroy, MDPrincipal InvestigatorLindner Center of HOPE