Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
NCT ID: NCT01017263
Last Updated: 2014-02-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
14 participants
INTERVENTIONAL
2009-12-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
17 Years
ALL
Yes
Sponsors
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Shire
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Scott H Kollins, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Child and Family Study Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00019063
Identifier Type: -
Identifier Source: org_study_id
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