Vyvanse in Children Aged 6 to 12 Years
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
🗓️ Study Start (Actual) 20 December 2023
🗓️ Primary Completion (Estimated) 30 November 2028
✅ Study Completion (Estimated) 30 November 2029
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 6 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 June 2022
  • First Submitted that Met QC Criteria 8 June 2022
  • First Posted 13 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 December 2023
  • Last Update Posted 21 December 2023
  • Last Verified December 2023