← Back to Search

Vyvanse for Childhood Obesity

Phase < 1
Recruiting
Led By Claudia Fox, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe obesity defined as BMI >/= 1.2 times the 95th percentile
Children ages 6 to <12 years at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of lisdexamfetamine to placebo in children who have difficulty maintaining a healthy weight.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if adding the medication Vyvanse (lisdexamfetamine) to lifestyle therapy helps kids with severe obesity better than just lifestyle therapy and a placebo. Kids are randomly assigned to one of these two groups.See study design
What are the potential side effects?
Vyvanse may cause increased heart rate, trouble sleeping, decreased appetite, dry mouth, anxiety and can potentially lead to dependence or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is significantly higher than what is considered severely obese for my age.
Select...
I am between 6 and 11 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in Body Mass Index

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Lifestyle therapy plus lisdexamfetamineActive Control1 Intervention
Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
Group II: Lifestyle therapy plus placeboPlacebo Group1 Intervention
Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,735 Total Patients Enrolled
Claudia Fox, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Lifestyle therapy Clinical Trial Eligibility Overview. Trial Name: NCT05416125 — Phase < 1
Childhood Obesity Research Study Groups: Lifestyle therapy plus placebo, Lifestyle therapy plus lisdexamfetamine
Childhood Obesity Clinical Trial 2023: Lifestyle therapy Highlights & Side Effects. Trial Name: NCT05416125 — Phase < 1
Lifestyle therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416125 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for enrollment in this clinical investigation?

"Data hosted on clinicaltrials.gov indicates that, as of September 1st 2022, this medical trial is no longer enrolling patients. Initially posted in July 2021 and last edited a year later, the study has since closed to new enrollees. Nevertheless, there are over 1000 other studies actively recruiting participants at present."

Answered by AI

Under what criteria can potential participants be accepted into this research project?

"This research is currently enrolling 40 children aged 6 to 12 with severe obesity (BMI of greater than or equal to 1.2 times the 95th percentile). In order for an application to be accepted, participants must have attempted lifestyle therapy in the past and their parent/guardian must provide written consent as well as the participant themselves providing assent."

Answered by AI

Is the age requirement for this trial inclusive of individuals over twenty years old?

"In accordance with the study's selection parameters, potential participants must be between 6 and 12 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vyvanse in Children Aged 6 to 12 Years
2023. "Vyvanse in Children Aged 6 to 12 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05416125.
~27 spots leftby Nov 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top