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