RecruitingPhase 4ACTRN12618000623291

Neural mechanisms of lisdexamfetamine in binge eating disorder.

Understanding the neural mechanisms of Lisdexamfetamine dimesylate (LDX) pharmacotherapy in binge-eating disorder.

Sponsor

University of Sydney

Enrollment

62 participants

Start Date

May 30, 2018

Study Type

Interventional

Conditions

Binge-Eating Disorder

Summary

While Lisdexamfetamine dimesylate (LDX) is indicated for moderate to severe binge-eating disorder (BED) in Australia, the exact mode of its therapeutic action in BED remains unknown. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that: 1. LDX will act by altering connectivity within and between brain circuits responsible for reward and inhibition. 2. A reduction in binge-eating behaviours will correlate with increased activity and connectivity of brain regions within reward and inhibition circuits.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating how lisdexamfetamine (LDX) — a medication approved for binge eating disorder in Australia — changes brain activity to reduce bingeing behaviour. Binge eating disorder involves repeated episodes of eating large amounts of food in a short time with a feeling of loss of control. LDX is effective, but researchers don't yet fully understand which brain circuits it works on, which limits our ability to predict who will benefit and to develop better treatments. People with moderate to severe binge eating disorder and healthy volunteers will undergo brain scans (MRI) before and after a course of LDX to measure how it changes connectivity in the brain's reward and impulse control circuits. Binge eating frequency and other outcomes will also be tracked. You may be eligible if you are aged 18–40, have a confirmed diagnosis of moderate to severe binge eating disorder (bingeing 3 or more days per week), have a BMI between 20 and 45, and do not have anorexia, bulimia, psychosis, heart disease, or a history of substance abuse. Healthy volunteers without any eating disorder or psychiatric history are also invited to participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Drug name: Lisdexamfetamine dimesylate Mode of administration: oral tablet Dose and duration of administration: Intervention is planned to be titrated. All binge-eating disorder patients will commen

Drug name: Lisdexamfetamine dimesylate Mode of administration: oral tablet Dose and duration of administration: Intervention is planned to be titrated. All binge-eating disorder patients will commence with 30mg once daily for 2 weeks, then increase to 50mg once daily for the next 2 weeks following a blood pressure check. At 4-weeks, all participants will receive a safety and dose check by a study clinician. The clinician will assess whether those responsive to the medication should maintain their dose of 50mg once daily for the next 4 weeks, or whether those non-responsive should increase their dose to 70mg once daily for the next 4 weeks. Strategies used to monitor adherence to the intervention will include: - Participant diary to be completed daily, including a checkbox for medication compliance. - Participants will be required to return all medication blister packs (used or unused) at the follow-up session, which will be counted for compliance rate. If less than 60% of tablets have been taken at this point, this will be viewed as non-compliant.