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
Results First Received: September 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
Glucose Intolerance
Obesity
Intervention: Drug: Lis-dexamphetamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Open Label Vyvanse 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.

Participant Flow:   Overall Study
    Open Label Vyvanse  
STARTED     14  
COMPLETED     2 [1]
NOT COMPLETED     12  
not eligible                 12  
[1] A total of 14 participants screened: 2 qualified and received drug the remaining 12 failed screen



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label Vyvanse All subjects receive Vyvanse.

Baseline Measures
    Open Label Vyvanse  
Number of Participants  
[units: participants]
  14  
Age  
[units: participants]
 
<=18 years     14  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.92  ± 2.73  
Gender  
[units: participants]
 
Female     8  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures

1.  Primary:   Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.   [ Time Frame: Baseline to end of study ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Scott Kollins, PhD
Organization: Duke UMC
phone: 9196810014
e-mail: scott.kollins@dm.duke.edu


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