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

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the effectiveness of lisdexamfetamine (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, LDX medication results in superior maintenance and longer-term outcomes compared with placebo.

Research Team

Carlos M Grilo, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+