Vyvanse in Children Aged 6 to 12 Years

Last updated: January 7, 2026
Sponsor: University of Minnesota
Overall Status: Active - Not Recruiting

Phase

1

Condition

Obesity

Diabetes Prevention

Treatment

Lisdexamfetamine Dimesylate

Lifestyle therapy

Clinical Study ID

NCT05416125
PEDS-2022-30981
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children ages 6 to <12 years at study entry

  • Severe obesity defined as BMI >/= 1.2 times the 95th percentile at the screeningvisit

  • Prior failed attempt of lifestyle therapy per parent/guardian report

  • Written informed consent of parent/legal guardian and written assent of participant

Exclusion

Exclusion Criteria:

  • Contraindications to lisdexamfetamine, including current or recent (< 14 days) useof monoamine oxidase inhibitor and known hypersensitivity to amphetamine products

  • Family history of sudden death or ventricular arrhythmia in any first or seconddegree relative with any of the following: sudden or unexplained death includingsudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantabledefibrillator).

  • 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 bloodpressure (DBP) >/= 95th percentile (on 3 separate occasions) at the screening ORbaseline/randomization visits

  • Tachycardia defined heart rate (HR) >/= 120 bpm (on 3 separate occasions) at thescreening 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 lipidmedication(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 12months

  • Any history of suicide attempt

  • Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh atthe screening or baseline/randomization visits

  • Children's Depressive Inventory 2 (CDE-2_ score >/= 70 (based on parent or childreport) at the screening or baseline/randomization visits

  • Concomitant use of tricyclic antidepressants, selective serotonin re-uptakeinhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs),lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort atany time during the study

  • Refusal to use adequate contraception (double barrier method or stable hormonalcontraception plus single barrier method, tubal ligation, or abstinence) in girls ofchildbearing potential

  • Inability to swallow test capsule (participants will have two opportunities)

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Lisdexamfetamine Dimesylate
Phase: 1
Study Start date:
December 20, 2023
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55414
    United States

    Site Not Available

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