Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

Duke University

Status and phase: Terminated; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Obesity; Glucose Intolerance

Treatments: Drug: Lis-dexamphetamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01017263

Pro00019063

Details and patient eligibility

About

The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.

Enrollment: 14 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male or female, ages between 8 and 17
• Body Mass Index > 30
• fasting blood sugar between 90-100 mg/dl
• 2 hour post prandial >140 <180 mg/dl
• meets criteria for a diagnosis of ADHD, any subtype

Exclusion criteria

• known cardiovascular disease or diabetes
• structural cardiac abnormalities, abnormal ECGs, family history of sudden death
• positive urine drug screen
• fasting blood sugar level > 126 mg/dl
• HbA1c > 6.5 %
• Weight > 300 lbs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Open label Vyvanse

Active Comparator group

Description:

Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.

Treatment:

Drug: Lis-dexamphetamine