NCT03397446

Lisdexamfetamine for Adults With Bulimia Nervosa

A Feasibility Study to Evaluate Lisdexamfetamine Dimesylate (Vyvanse) in Adults With Bulimia Nervosa

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Aaron Keshen · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The relatively high rates of bulimia nervosa (BN) in attention-deficit/hyperactivity disorder (ADHD) cohorts suggest a relationship between the two disorders. Interestingly, case studies involving this comorbid population have observed improvements in BN symptoms when given psychostimulants for ADHD. Case studies involving BN patents without this comorbidity have also demonstrated BN symptom improvements upon psychostimulant initiation. Recent studies have also found support for the use of lisdexamfetamine dimesylate, a psychostimulant approved for ADHD, for treating moderate to severe binge eating disorder, an eating disorder akin to BN. Given these findings, there is reason to believe that psychostimulants may also be capable of treating bulimia nervosa. Ultimately, the investigators would like to conduct a large study that examines whether people who are diagnosed with BN will have fewer episodes of binge eating and purging when they are treated with the psychostimulant medication, lisdexamfetamine dimesylate (LDX). However, preliminary data would be helpful prior to undertaking such a large project. To this end, the aim of the current study is to learn more about a) enrolment rates, b) dropout rates, c) the applicability of our eligibility criteria, d) the potential effects of LDX on novel outcome measures for studying decision-making in BN, e) preliminary safety data, and f) estimates of treatment effect. Participants (n = 30) will be instructed to take LDX once daily for two months while undergoing routine testing and monitoring to gather preliminary safety and treatment data. The research will take place at the Nova Scotia Health Authority Eating Disorder Clinic.

Conditions

• Bulimia Nervosa

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine dimesylate	50mg or 70mg oral capsules taken once-daily for to 2 months. The trial will begin with a 4-week titration phase, where patients will titrate up to a dose of 50mg/day or 70mg/day, followed by a 4-week maintenance phase. No dose changes will be permitted during the maintenance phase.

Timeline

• Start date: 2018-06-21
• Primary completion: 2020-05-19
• Completion: 2020-05-19
• First posted: 2018-01-12
• Last updated: 2020-11-27

Locations

1 site across 1 country: Canada