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
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017263
First received: November 19, 2009
Last updated: February 18, 2014
Last verified: September 2013
  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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial. [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
    The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.


Enrollment: 14
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
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.
Drug: Lis-dexamphetamine
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Scott H Kollins, PhD Duke University
  More Information

Additional Information:
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
Results First Received: September 13, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
ADHD
Glucose Intolerance
Obesity
Vyvanse

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Glucose Intolerance
Hyperkinesis
Obesity
Attention Deficit and Disruptive Behavior Disorders
Body Weight
Dyskinesias
Glucose Metabolism Disorders
Hyperglycemia
Mental Disorders
Mental Disorders Diagnosed in Childhood
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014