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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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
Intervention: Drug: Lis-dexamphetamine

  Participant Flow

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
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
COMPLETED   2 [1] 
not eligible                12 
[1] A total of 14 participants screened: 2 qualified and received drug the remaining 12 failed screen

  Baseline Characteristics

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
Open Label Vyvanse All subjects receive Vyvanse.

Baseline Measures
   Open Label Vyvanse 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   14 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 10.92  (2.73) 
[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

  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.

  More Information

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 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