Vyvanse in Children Aged 6 to 12 Years

Early Phase 1

Recruiting

• Conditions: Obesity, Childhood
• Interventions: Drug: Lisdexamfetamine Dimesylate; Behavioral: Lifestyle therapy

• Registration Number: NCT05416125
• Lead Sponsor: University of Minnesota

Brief 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.

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 Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2023-12-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2028-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 at the screening OR baseline/randomization visits
• Tachycardia defined heart rate (HR) >/= 120 bpm 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle therapy plus lisdexamfetamine	Lisdexamfetamine Dimesylate	Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
Lifestyle therapy plus placebo	Lifestyle therapy	Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percent change in Body Mass Index	24 weeks	The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States