40 Participants Needed

Vyvanse for Childhood Obesity

CF
Overseen ByClaudia Fox, MD

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?

Family-based behavioral interventions have been shown to be effective and safe for treating childhood obesity, focusing on diet, physical activity, and behavior changes. These interventions are most successful when they involve family participation and target lifestyle changes.12345

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

CF

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

My BMI is significantly higher than what is considered severely obese for my age.
Written informed consent of parent/legal guardian and written assent of participant
Prior failed attempt of lifestyle therapy per parent/guardian report
See 1 more

Exclusion Criteria

I have diabetes (type 1 or 2).
I am not taking medications like antidepressants, lithium, fentanyl, or St. John's wort.
Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lifestyle therapy
  • Lisdexamfetamine Dimesylate
Trial Overview 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.
Participant Groups
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.

Lifestyle therapy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lifestyle therapy for:
  • Childhood obesity
  • Weight management
🇪🇺
Approved in European Union as Lifestyle therapy for:
  • Childhood obesity
  • Weight management

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.
Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.
Current approaches to the management of pediatric overweight and obesity.Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]
Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.
While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.
Treatment of pediatric obesity.Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]
Obesity in children and adolescents is a complex issue that requires treatment strategies based on the underlying physiology, biochemistry, and genetics, aiming to prevent related health problems and improve quality of life.
Successful obesity treatment should follow a chronic disease model, incorporating a range of approaches including healthy lifestyle changes, pharmacotherapy, and medical devices, while recognizing that bariatric surgery is often not a preferred option for patients and families.
Therapeutic Options to Treat Pediatric Obesity.Browne, AF.[2017]

References

Current approaches to the management of pediatric overweight and obesity. [2021]
Treatment of pediatric obesity. [2007]
Therapeutic Options to Treat Pediatric Obesity. [2017]
Practitioner review: bridging the gap between research and clinical practice in pediatric obesity. [2015]
Pharmacotherapy in pediatric obesity: current agents and future directions. [2021]
Lisdexamfetamine: A Review in Binge Eating Disorder. [2018]
[Pharmacological properties and clinical effects of the ADHD drug, Lisdexamfetamine (Vyvanse&#174; capsules 20&#8197;mg and 30&#8197;mg)]. [2020]
Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD. [2018]
Marketing Messages in Continuing Medical Education (CME) Modules on Binge-Eating Disorder (BED). [2021]
Lisdexamfetamine in the treatment of adolescents and children with attention-deficit/hyperactivity disorder. [2021]
An overview of pediatric obesity. [2007]
Current and future pharmacotherapies for obesity in children and adolescents. [2023]
Current Perspectives on the Role of Very-Low-Energy Diets in the Treatment of Obesity and Type 2 Diabetes in Youth. [2021]
Pharmacological treatment of obesity in children and adolescents: current status and perspectives. [2010]
The treatment of obesity in children and adolescents: consensus position statement of the Italian society of pediatric endocrinology and diabetology, Italian Society of Pediatrics and Italian Society of Pediatric Surgery. [2023]
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