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Lisdexamfetamine for Post-Bariatric Surgery Weight Control

Phase 2 & 3
Waitlist Available
Led By Carlos Grilo, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL
Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-treatment to the 12-month follow-up
Awards & highlights

Study Summary

This trial will test whether lisdexamfetamine can help people with uncontrolled eating and weight issues after bariatric surgery, when other treatments haven't worked.

Who is the study for?
This trial is for adults aged 18-64 who've had bariatric surgery (gastric bypass or sleeve gastrectomy) about ten months ago, struggle with loss-of-control eating post-surgery, and didn't respond to initial treatments. Participants must be in good health otherwise, not on certain medications including weight loss drugs or stimulants, and without severe psychiatric conditions or unstable medical disorders.Check my eligibility
What is being tested?
The study tests if lisdexamfetamine can help control eating and manage weight better than a placebo in those who haven't improved after previous treatments following bariatric surgery. It's a controlled trial where participants are randomly given either the medication or a placebo.See study design
What are the potential side effects?
Lisdexamfetamine may cause side effects like dry mouth, insomnia, increased heart rate and blood pressure, anxiety, decreased appetite, nausea, dizziness. Not everyone will experience these side effects; some might have none at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started losing control over my eating 6 months after weight loss surgery and didn't improve with 4 months of treatment.
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I have had weight loss surgery, either gastric bypass or sleeve gastrectomy.
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I am between 18 and 64 years old.
Select...
It has been about 10 months since my surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Mass Index (BMI)
Loss-of-Control Eating Frequency

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lisdexamfetamine dimesylateExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,836 Previous Clinical Trials
2,727,213 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,337 Previous Clinical Trials
4,319,447 Total Patients Enrolled
Carlos Grilo, PhDPrincipal InvestigatorYale School of Medicine
1 Previous Clinical Trials
136 Total Patients Enrolled

Media Library

Lisdexamfetamine Dimesylate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04599504 — Phase 2 & 3
Binge Eating Disorder Research Study Groups: Lisdexamfetamine dimesylate, Placebo
Binge Eating Disorder Clinical Trial 2023: Lisdexamfetamine Dimesylate Highlights & Side Effects. Trial Name: NCT04599504 — Phase 2 & 3
Lisdexamfetamine Dimesylate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599504 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Lisdexamfetamine Dimesylate (Medication) a new medication?

"There are currently 6 clinical trials studying the effects of Lisdexamfetamine Dimesylate (Medication), 3 of which have reached Phase 3. Most of these studies are taking place in Iowa City, although there are a total of six locations running trials for this medication."

Answered by AI

To whom does this study's inclusion criteria apply?

"This trial is looking for 60 individuals that have experienced loss of control eating and meet the following age, surgery, and health requirements: 18-64 years old, laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy surgery ten months prior, regular loss of control eating six months after bariatric surgery, treatment nonresponders to a four-month medication and/or BWL trial. Lastly, participants must be available for 15 months and provide written informed consent."

Answered by AI

Does this trial have open slots for participants?

"Unfortunately, this trial is not currently open to recruitment. Although the study was posted on 1/2/2022 and updated as recently as 10/4/2022, there are no plans to recruit patients at this time. However, there are 344 other studies concerning loss of control eating and 6 Lisdexamfetamine Dimesylate (Medication) trials that are actively recruiting participants."

Answered by AI

Are there a lot of people involved in this experiment?

"At the moment, this trial is not looking for new participants. The listing was first put up on January 2nd, 2022 and has been edited most recently on October 4th, 2022. For other trials, there are currently 344 that are recruiting patients with loss of control eating and 6 for Lisdexamfetamine Dimesylate (Medication)."

Answered by AI
~29 spots leftby May 2026