Overview

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