Trial Outcomes & Findings for The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading (NCT NCT00733356)
NCT ID: NCT00733356
Last Updated: 2018-02-14
Results Overview
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.
COMPLETED
PHASE4
42 participants
baseline and final day (lab school Assessments)
2018-02-14
Participant Flow
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.
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.
Participant milestones
| Measure |
ADHD With Vyvanse Treatment
All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
|
|---|---|
|
Vyvanse Dose Titration
STARTED
|
28
|
|
Vyvanse Dose Titration
COMPLETED
|
26
|
|
Vyvanse Dose Titration
NOT COMPLETED
|
2
|
|
Modified Lab School, Reading Evaluation
STARTED
|
26
|
|
Modified Lab School, Reading Evaluation
COMPLETED
|
26
|
|
Modified Lab School, Reading Evaluation
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading
Baseline characteristics by cohort
| Measure |
ADHD With Vyvanse Treatment
n=28 Participants
All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
|
|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
9.3 years
STANDARD_DEVIATION 1.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: baseline and final day (lab school Assessments)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.
Outcome measures
| Measure |
ADHD With Vyvanse Treatment
n=26 Participants
All enrolled subjects will be titrated to an effective dose of vyvanse. Reading abilities were tested in a modified lab school day.
|
|---|---|
|
Gray Oral Reading Rest, Fourth Edition (GORT-4)
|
8.27 units on a scale
Standard Deviation 1.84
|
Adverse Events
ADHD With Vyvanse Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kinberley Lakes
University of California Irvine Child Development Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place