The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading (VBHR)
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|ClinicalTrials.gov Identifier: NCT00733356|
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder||Drug: Vyvanse||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Experimental: Vyvanse Treatment
All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication.
Subjects will participate in an open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day) during the week leading up to their final visit. During the study subjects will take their prescribed dose once a day in the morning with breakfast.
Other Name: lisdexamfetamine dimesylate
- Gray Oral Reading Rest, Fourth Edition (GORT-4) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733356
|United States, California|
|University of California, Irvine Child Development Center|
|Irvine, California, United States, 92697|
|Principal Investigator:||Kimberley Lakes, PhD||UC Irvine|