Obesity, Childhood
Conditions
Keywords
Obesity
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 placebo. Participants will receive therapy for 24 weeks.
Interventions
DRUGLisdexamfetamine Dimesylate
Vyvanse treatment
BEHAVIORALLifestyle therapy
Lifestyle treatment
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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 (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in Body Mass Index | 24 weeks | The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24 |
Countries
United States
Outcome results
None listed