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The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading (VBHR)

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.
 
ClinicalTrials.gov Identifier: NCT00733356
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Kimberley Lakes, University of California, Irvine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single;   Primary Purpose: Basic Science
Condition Attention Deficit/Hyperactivity Disorder
Intervention Drug: Vyvanse
Enrollment 42
Recruitment Details

Subjects were recruited through flyers and other advertising and were seen in a researach clinic setting. Subjects were recruited from july 2008 until May 2009. A primary diagnosis of ADHD was confirmed.

All subjects were also given a K-BIT intelligence test and had to achieve a score of at least 80 to be enrolled.

Pre-assignment Details All subjects who met study criteria for ADHD and intellectual ability who were also healthy and had no other co-morbid diagnosis except possible ODD were enrolled in the study. Any subjects taking stimulant medication before the trial did a 2-day washout before baseline. 42 subjects consented, 5 didn't meet criteria, 9 withdrew consent.
Arm/Group Title ADHD With Vyvanse Treatment
Hide Arm/Group Description All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
Period Title: Vyvanse Dose Titration
Started 28
Completed 26
Not Completed 2
Period Title: Modified Lab School, Reading Evaluation
Started 26
Completed 26
Not Completed 0
Arm/Group Title ADHD With Vyvanse Treatment
Hide Arm/Group Description All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
Subjects who met study criteria for ADHD as a primary diagnosis and no other major psychiatric diagnosis and had an IQ score at 80 or above and continued to be willing to participate in Vyvanse treatment phase. All subjects received their first reading tests at baseline visit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
28
 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 28 participants
9.3  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
6
  21.4%
Male
22
  78.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Gray Oral Reading Rest, Fourth Edition (GORT-4)
Hide Description

The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.

The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study.

Time Frame baseline and final day (lab school Assessments)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADHD With Vyvanse Treatment
Hide Arm/Group Description:
All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.27  (1.84)
Time Frame 12 weeks from initial screening through 30 days of follow-up.
Adverse Event Reporting Description adverse event data were collected in weekly visits based on spontaneous parent report until final study data. Any ongoing adverse events were again assessed at the 30 day follow-up call.
 
Arm/Group Title ADHD With Vyvanse Treatment
Hide Arm/Group Description All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
All-Cause Mortality
ADHD With Vyvanse Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
ADHD With Vyvanse Treatment
Affected / at Risk (%)
Total   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADHD With Vyvanse Treatment
Affected / at Risk (%)
Total   0/26 (0.00%) 

This is a small sample of well characterized children with ADHD who were only treated for 1 month.

In addition, we did not select for children with reading disability.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kinberley Lakes
Organization: University of California Irvine Child Development Center
Phone: 949-824-3009
EMail: klakes@uci.edu
Layout table for additonal information
Responsible Party: Kimberley Lakes, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00733356    
Other Study ID Numbers: VBHR
First Submitted: August 11, 2008
First Posted: August 13, 2008
Results First Submitted: June 21, 2013
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018