Vyvanse in Children Aged 6 to 12 Years

August 5, 2026 updated by: University of Minnesota

Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children ages 6 to <12 years at study entry
  • Severe obesity defined as BMI >/= 1.2 times the 95th percentile at the screening visit
  • Prior failed attempt of lifestyle therapy per parent/guardian report
  • Written informed consent of parent/legal guardian and written assent of participant

Exclusion Criteria:

  • Contraindications to lisdexamfetamine, including current or recent (< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
  • Family history of sudden death or ventricular arrhythmia in any first or second degree relative with any of the following: sudden or unexplained death including sudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantable defibrillator).
  • Any history of fainting or seizure from exercise, startle, or fright
  • Clinically significant congenital or structural heart disease or arrhythmia
  • BMI <1.2 times the 95th percentile at the baseline/randomization visits
  • Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile (on 3 separate occasions) at the screening OR baseline/randomization visits
  • Tachycardia defined heart rate (HR) >/= 120 bpm (on 3 separate occasions) at the screening OR baseline/randomization visits
  • Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine
  • History of chemical dependency
  • Diabetes mellitus (type 1 or 2)
  • Current or recent (< 3 months) use of anti-obesity medication(s)
  • Previous bariatric surgery
  • Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s)
  • Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN
  • Fasting glucose >/= 126 mg/dL
  • History of mania, schizophrenia, bipolar disorder, or psychosis
  • Unstable depression or anxiety that has required hospitalization in the past 12 months
  • Any history of suicide attempt
  • Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh at the screening or baseline/randomization visits
  • Children's Depressive Inventory 2 (CDE-2_ score >/= 70 (based on parent or child report) at the screening or baseline/randomization visits
  • Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort at any time during the study
  • Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential
  • Inability to swallow test capsule (participants will have two opportunities)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lifestyle therapy plus placebo
Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.
Behavioral: Lifestyle therapy
Lifestyle treatment
Active Comparator: Lifestyle therapy plus lisdexamfetamine
Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
Drug: Lisdexamfetamine Dimesylate
Vyvanse treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in Body Mass Index
Time Frame: 24 weeks
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Claudia Fox, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

June 23, 2026

Study Completion (Actual)

June 23, 2026

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDS-2022-30981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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