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

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ClinicalTrials.gov Identifier: NCT01017263
Recruitment Status : Terminated (Due very high screen fail rate, pre study feasibility not consistent with screened population.)
First Posted : November 20, 2009
Results First Posted : February 20, 2014
Last Update Posted : February 20, 2014
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder
Glucose Intolerance
Obesity
Intervention Drug: Lis-dexamphetamine
Enrollment 14
Recruitment Details Potential participants are pre-screened at the Duke Obesity Clinic. Eligible participants then come to the Duke ADHD Clinic for their first study visit.
Pre-assignment Details At the screening visit, psychiatric evaluation and fasting labs were obtained to determine eligibility. Of the 14 subjects only 2 qualified and received study drug. Reasons for screen fails: 8-did not meet lab parameters for glucose intolerance, 1-elevated BP, 1- elevated TSH, 1- doing well with current ADHD treatment, 1- diagnosed with depression.
Arm/Group Title Open Label Vyvanse
Hide Arm/Group Description Eligible subjects will be dispensed open label LDX (Vyvanse). 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.
Period Title: Overall Study
Started 14
Completed 2 [1]
Not Completed 12
Reason Not Completed
not eligible             12
[1]
A total of 14 participants screened: 2 qualified and received drug the remaining 12 failed screen
Arm/Group Title Open Label Vyvanse
Hide Arm/Group Description All subjects receive Vyvanse.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
14
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
10.92  (2.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
Hide Description 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.
Time Frame Baseline to end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study terminated early - no analysis performed on the single subject with data.
Arm/Group Title Vyvanse Open Label
Hide Arm/Group Description:
Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were 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 was allowed.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Vyvanse
Hide Arm/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.
All-Cause Mortality
Open Label Vyvanse
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Vyvanse
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label Vyvanse
Affected / at Risk (%)
Total   0/14 (0.00%) 
Study was terminated due to the high number of failures of lab criteria for glucose intolerance which is one of the entry criterion. No data were analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Scott Kollins, PhD
Organization: Duke UMC
Phone: 9196810014
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01017263     History of Changes
Other Study ID Numbers: Pro00019063
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: September 13, 2013
Results First Posted: February 20, 2014
Last Update Posted: February 20, 2014