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

• 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: Kimberley Lakes
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		ADHD With Vyvanse Treatment
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
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

Outcome Measures

1. Primary Outcome

Title	Gray Oral Reading Rest, Fourth Edition (GORT-4)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ADHD With Vyvanse Treatment
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)

Adverse Events

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
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	--/--
Serious Adverse Events
	ADHD With Vyvanse Treatment
	Affected / at Risk (%)
Total	0/26 (0.00%)
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%)

Limitations and Caveats

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.

More Information

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

• Name/Title: Kinberley Lakes
• Organization: University of California Irvine Child Development Center
• Phone: 949-824-3009
• EMail: klakes@uci.edu

Publications of Results:

Wigal SB, Maltas S, Crinella F, Stehli A, Steinhoff K, Lakes K, Schuck S. Reading performance as a function of treatment with lisdexamfetamine dimesylate in elementary school children diagnosed with ADHD. J Atten Disord. 2012 Jan;16(1):23-33. doi: 10.1177/1087054710378008. Epub 2010 Oct 26.

• 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