Vyvanse in Children Aged 6 to 12 Years

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Drug: Lisdexamfetamine Dimesylate
* Behavioral: Lifestyle therapy


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lifestyle therapy plus placebo<br>Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks. | Behavioral: Lifestyle therapy<br>* Lifestyle treatment<br>|
| Active Comparator: Lifestyle therapy plus lisdexamfetamine<br>Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks. | Drug: Lisdexamfetamine Dimesylate<br>* Vyvanse treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Body Mass Index | The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity