Vyvanse for Childhood Obesity
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain medications, such as monoamine oxidase inhibitors, psychostimulants, anti-obesity medications, and some antidepressants, before joining. If you're on any of these, you may need to stop them to participate.
What data supports the effectiveness of the treatment for childhood obesity?
Is Vyvanse (Lisdexamfetamine Dimesylate) generally safe for humans?
Vyvanse (Lisdexamfetamine Dimesylate) has been generally well tolerated in clinical trials for conditions like binge eating disorder and ADHD. Common side effects include dry mouth, headache, insomnia, decreased appetite, and irritability, but these are usually mild. Long-term use has not been associated with an increase in adverse events.678910
How does the drug Vyvanse differ from other treatments for childhood obesity?
Vyvanse (Lisdexamfetamine Dimesylate) is unique for childhood obesity as it combines lifestyle therapy with a medication originally used for ADHD, potentially addressing both behavioral and biological factors contributing to obesity. This dual approach may offer a novel way to help children manage their weight by targeting underlying issues like impulse control and appetite regulation.1112131415
What is the purpose of this trial?
This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.
Research Team
Claudia Fox, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for children aged 6 to <12 with severe obesity, who have tried lifestyle therapy without success. They must not have a history of heart issues, drug abuse, or certain mental health conditions. Girls able to have children must agree to use reliable contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lifestyle therapy
- Lisdexamfetamine Dimesylate
Lifestyle therapy is already approved in United States, European Union for the following indications:
- Childhood obesity
- Weight management
- Childhood obesity
- Weight management
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor