Vyvanse in Children Aged 6 to 12 Years

• Status: Not yet recruiting
• Trial end date: 2029-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota
• Treatments: Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• Children ages 6 to <12 years at study entry

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

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

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

• Clinically significant congenital or structural heart disease or arrhythmia unless otherwise cleared by cardiology

• Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile on 3 separate occasions

• Tachycardia defined heart rate (HR) >/= 120 bpm on 3 separate occasions

• 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)

• Diagnosed monogenic or syndromic obesity

• 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

• Inability to swallow capsules whole