Overview
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.
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