What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder, such as lisdexamfetamine, which increases norepinephrine and dopamine levels, often have side effects including decreased appetite, insomnia, dry mouth, increased heart rate, and anxiety. Other similar medications, like methylphenidate, share these side effects and may also cause gastrointestinal disturbances, weight loss, and carry a potential for abuse or dependence.

What prior FDA approvals exist?

Lisdexamfetamine (Vyvanse) is the first and only medication approved by the FDA specifically for the treatment of Binge Eating Disorder (BED). It works by increasing levels of norepinephrine and dopamine, which helps reduce appetite and improve control over eating behaviors. Other medications that have been used off-label for BED include certain antidepressants like selective serotonin reuptake inhibitors (SSRIs) and antiepileptic drugs, but these do not share the same mechanism of action as lisdexamfetamine.

What other types of research exist?

Promising novel alternatives to Lisdexamfetamine for Binge Eating Disorder patients include: 1) Naltrexone/Bupropion combination, which targets the reward system and appetite regulation; 2) Topiramate, an anticonvulsant that has shown efficacy in reducing binge episodes; and 3) GLP-1 receptor agonists like Liraglutide, which can reduce appetite and promote weight loss.

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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

Must not have

Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder

Has current uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from post-treatment to the 12-month follow-up

Summary

This trial is testing whether the drug lisdexamfetamine can help people who have had weight-loss surgery but still struggle with controlling their eating and weight. The study focuses on those who did not improve with initial treatments, to see if this medication works better.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe kidney, liver, nerve, lung condition, or another serious health issue.

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My blood pressure is high and not under control.

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I am allergic to LDX or similar stimulant medications.

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My current medication cannot be combined with the study drug.

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I am currently taking medication for ADHD or using psychostimulants.

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My blood pressure or heart rate is higher than normal and untreated.

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My diabetes is not currently under control.

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My thyroid is underactive and not yet treated, confirmed by two tests.

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I am currently receiving treatment for an eating disorder or to lose weight.

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I am currently taking MAOI, SSRI, or strong CYP2D6 inhibitors.

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I have gallbladder disease.

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I have a history of heart disease, arrhythmias needing medication, or stroke.

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I am currently taking medication to lose weight.

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I have had issues with LDX or similar medications before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from post-treatment to the 12-month follow-up

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

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

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Binge Eating Disorder (BED) include medications like Lisdexamfetamine, which increases norepinephrine and dopamine levels to reduce appetite and improve control over eating behaviors. This is crucial for BED patients as it helps regulate the brain's reward system, reducing the compulsion to binge eat. Other treatments, such as selective serotonin reuptake inhibitors (SSRIs), work by increasing serotonin levels, which can improve mood and reduce binge eating episodes. These mechanisms are important because they address the underlying neurochemical imbalances that contribute to the loss of control over eating, thereby helping patients achieve better management of their eating behaviors.

Growth and Puberty in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder.The use of stimulant medications for non-core aspects of ADHD and in other disorders.Lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double-blind, placebo-controlled study.