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Lisdexamfetamine for Binge Eating Disorder and Obesity

Phase 3
Waitlist Available
Led By Carlos M Grilo, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 64 years old
Able to travel to study location (New Haven, CT) for weekly visits
Must not have
Current uncontrolled type I or II diabetes mellitus
Current uncontrolled thyroid illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up
Awards & highlights
Pivotal Trial

Summary

This trial will test whether lisdexamfetamine (LDX) is more effective than placebo as a maintenance therapy for binge-eating disorder (BED) in obese patients.

Who is the study for?
This trial is for adults aged 18-64 with binge-eating disorder and obesity (BMI between 27-50, depending on other health conditions). Participants must be able to commit to an 18-month study period in New Haven, CT. Exclusions include uncontrolled hypertension or diabetes, allergies to the medication, certain medication use (MAOIs, SSRIs), pregnancy without contraception use, severe mental illness requiring intensive treatment, substance abuse disorders excluding smoking.
What is being tested?
The effectiveness of lisdexamfetamine (LDX) as a maintenance therapy for binge-eating disorder in obese patients is being tested. The study compares LDX against a placebo in individuals who responded well to initial treatments. It aims to determine if LDX can maintain those benefits over the long term.
What are the potential side effects?
Lisdexamfetamine may cause side effects such as dry mouth, insomnia, increased heart rate and blood pressure, anxiety or jitteriness. As it's similar to stimulant medications used for ADHD treatment but tailored for binge-eating disorder here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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I can travel to New Haven, CT for weekly visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not currently under control.
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My thyroid condition is not under control.
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I am allergic to the study medication or similar stimulants.
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My high blood pressure is not under control.
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I am prone to having seizures.
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I have a history of serious heart conditions or high blood pressure.
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I do not have severe kidney, liver, nerve, lung diseases or other serious health issues.
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I have had issues with LDX or similar medications before.
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I am currently taking medication for depression or other conditions that affects my brain's chemical balance.
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I am currently taking Vyvanse, Wellbutrin, Zyban, Naltrexone, or Contrave.
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I am currently taking opioid pain medications.
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I am not taking any medications that would interfere with the study drugs.
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I am not pregnant, breastfeeding, and I agree to use contraception.
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I am currently using medication for ADHD or psychostimulants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from post-treatment to the 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-treatment to the 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Binge-Eating Relapse
Secondary study objectives
Binge-Eating Frequency
Body Mass Index (BMI)
Depressive Symptoms
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LDXActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,441 Previous Clinical Trials
4,324,784 Total Patients Enrolled
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,040,318 Total Patients Enrolled
Carlos M Grilo, Ph.D.Principal InvestigatorYale University
4 Previous Clinical Trials
306 Total Patients Enrolled

Media Library

Cognitive-Behavioral Clinical Trial Eligibility Overview. Trial Name: NCT03926052 — Phase 3
Binge Eating Disorder Research Study Groups: LDX, Placebo
Binge Eating Disorder Clinical Trial 2023: Cognitive-Behavioral Highlights & Side Effects. Trial Name: NCT03926052 — Phase 3
Cognitive-Behavioral 2023 Treatment Timeline for Medical Study. Trial Name: NCT03926052 — Phase 3
~1 spots leftby Dec 2024
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