Status:
ACTIVE_NOT_RECRUITING
Vyvanse in Children Aged 6 to 12 Years
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Childhood
Eligibility:
All Genders
6-12 years
Phase:
EARLY_PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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 (on 3 separate occasions) at the screening OR baseline/randomization visits
- Tachycardia defined heart rate (HR) \>/= 120 bpm (on 3 separate occasions) 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
- Inability to swallow test capsule (participants will have two opportunities)
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05416125
Start Date
December 20 2023
End Date
July 31 2027
Last Update
January 9 2026
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414