MedTrace Logo

Vyvanse in Children Aged 6 to 12 Years

NCT05416125 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-01-09

No results posted yet for this 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.

Conditions

  • Obesity, Childhood

Interventions

DRUG

Lisdexamfetamine Dimesylate

Vyvanse treatment

BEHAVIORAL

Lifestyle therapy

Lifestyle treatment

Sponsors & Collaborators

Principal Investigators

  • Claudia Fox, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416125 on ClinicalTrials.gov