vyvanse in children aged 6 to 12 years

Conditions: Obesity, Childhood

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.

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.

Eligibility criteria:
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

Keywords: obesity