Vyvanse in Children Aged 6 to 12 Years

Obesity, Childhood Clinical Trial

Official title:

Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416125
• Other study ID #: PEDS-2022-30981
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 20, 2023
• Est. completion date: November 30, 2029

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: Claudia Fox, MD
• Phone: (612) 626-6616
• Email: lusc0001[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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 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

• Clinically significant congenital or structural heart disease or arrhythmia

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

• Tachycardia defined heart rate (HR) >/= 120 bpm

• Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine

• History of chemical dependency

• Positive urine drug screen

• 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) of type 4 or 5 in past month

• Children's Depressive Inventory 2 (CDE-2_ score >/= 70

• 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

• 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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Drug:
• Lisdexamfetamine Dimesylate
Vyvanse treatment

Behavioral:
• Lifestyle therapy
Lifestyle treatment

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Body Mass Index	The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24	24 weeks