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

This study has been terminated.
(Due very high screen fail rate, pre study feasibility not consistent with screened population.)
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017263
First received: November 19, 2009
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Glucose Intolerance
Obesity
 Drug: Lis-dexamphetamine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vyvanse and Glucose Intolerance in Children With ADHD and Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Fasting and 2 hour post prandial glucose, insulin and HbA1c. [ Time Frame: Screening, Visit 7 and 11(end of study) ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: December 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open label Vyvanse
All subjects receive Vyvanse.
 Drug: Lis-dexamphetamine
Lis-dexamphetamine starting at 20mg once a day dose, increased weekly by 10mg increments up to a maximum dose of 70mg.
Other Name: Vyvanse, LDX

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017263

Locations
United States, North Carolina
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Shire Development LLC
Investigators
Principal Investigator: Scott H Kollins, PhD Duke University
  More Information

Additional Information:
Duke ADHD Program website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01017263     History of Changes
Other Study ID Numbers: Pro00019063
Study First Received: November 19, 2009
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
ADHD
Glucose Intolerance
Obesity
Vyvanse

Additional relevant MeSH terms:
Obesity
Attention Deficit Disorder with Hyperactivity
Glucose Intolerance
Hyperkinesis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013