Lisdexamfetamine for Binge Eating Disorder and Obesity

Overseen By Valentina Ivezaj, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Yale University

Must not be taking: Psychostimulants, ADHD medications, MAOIs, SSRIs

Disqualifiers: Heart disease, Severe mental illness, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the medication lisdexamfetamine (LDX) helps people with binge-eating disorder (BED) and obesity maintain treatment results better than a placebo. It seeks to determine if LDX provides longer-lasting benefits for those who have already responded well to initial treatments. Participants will receive either LDX or a placebo to compare outcomes. Suitable candidates have BED, a BMI over 27, and no certain medical conditions like heart problems or current stimulant use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications to join the trial. The study excludes participants who are currently using medications like LDX, Bupropion, Naltrexone, or Contrave, as well as those taking MAOIs, SSRIs, or strong inhibitors of CYP2D6. If you're on any of these, you might need to stop them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisdexamfetamine (LDX) is generally safe for people with binge eating disorder (BED). One study found that LDX was more effective than a placebo in reducing the number of binge eating days each week, indicating that LDX can help manage BED without causing major problems.

Participants taking LDX reported better focus and some weight loss, which are positive effects. These results suggest that LDX may help with appetite and feelings of reward, which are part of BED.

While studies indicate that LDX is effective and generally safe, some side effects might still occur, as with any medication. However, the evidence so far suggests that LDX is a reasonably safe option for treating BED. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for binge-eating disorder?

Researchers are excited about Lisdexamfetamine for binge eating disorder and obesity because it offers a unique approach compared to existing treatments. Unlike the standard therapies that generally focus on appetite suppression or psychological interventions, Lisdexamfetamine acts on the brain's neurotransmitters, particularly targeting dopamine and norepinephrine. This mechanism can help regulate the urge to binge eat by addressing underlying neurological pathways. Additionally, Lisdexamfetamine has shown potential for rapid effectiveness, which could provide quicker relief for patients struggling with these conditions.

What evidence suggests that lisdexamfetamine might be an effective treatment for binge-eating disorder?

Research has shown that lisdexamfetamine (LDX), which participants in this trial may receive, effectively treats binge-eating disorder (BED). Studies have found that LDX reduces binge-eating episodes and can lead to weight loss for many patients. Participants in these studies reported feeling less hungry and eating less when taking LDX. Evidence also suggests that improvements in BED symptoms can begin soon after starting treatment with LDX. Overall, LDX appears to be a promising option for managing BED in patients with obesity. ^{2 3 4 6 7}

Who Is on the Research Team?

Carlos M Grilo, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The study team is available for the duration of the treatment and follow-up period (18 months).

I can travel to New Haven, CT for weekly visits.

You have binge-eating disorder, which means you frequently eat large amounts of food in a short period of time.

Exclusion Criteria

My diabetes is not currently under control.

I have a condition affecting my gallbladder.

My thyroid condition is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lisdexamfetamine (LDX) medication as a maintenance therapy for binge-eating disorder

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral
• Lisdexamfetamine Dimesylate

Trial Overview 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.

How Is the Trial Designed?

Group I: LDX Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34461386/

Lisdexamfetamine and binge-eating disorder: A systematic ... There is consistent evidence from clinical studies that LDX is an effective treatment for BED and that the drug reduces the BED symptoms and body weight of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772598724000412

Patient perceptions of lisdexamfetamine as a treatment for ... Lisdexamfetamine (LDX) reduced binge eating in most patients. High perceived efficacy of LDX was associated with improved focus and weight loss.

3. nature.com nature.com/articles/s41398-021-01770-4

The effects of lisdexamfetamine dimesylate on eating ... LDX reduced self-reported appetite ratings and intake of both a pasta meal and a palatable cookie snack. LDX also decreased the eating rate of pasta but not of ...

4. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00796-x

Secondary outcomes and qualitative findings of an open-label ... Robust evidence supports lisdexamfetamine dimestylate (LDX) as an effective treatment for binge eating in the context of binge eating disorder ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5573905/

Time course of the effects of lisdexamfetamine dimesylate ... These results suggest that LDX reduces both binge eating behavior and binge eating‐related psychopathology soon after treatment is initiated.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4793109/

Results of Two Pivotal Phase 3 Randomized Controlled Trials LDX (50 and 70 mg/day) was superior to placebo in decreasing binge eating days/week from baseline and improving binge eating–related key secondary endpoints.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38872181/

Exploring bi-directional impacts of Lisdexamfetamine ... This study provides preliminary evidence that for people with BED, LDX may be effective at improving co-occurring symptoms of eating disorder psychopathology ...