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

Launched by KIMBERLEY LAKES · Aug 12, 2008

Keywords

ClinConnect Summary

This is a single-blind study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension over a period of approximately 6 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.

The study will consist of periods detailed below:

Screening and Washout. Subjects will be screened up to four weeks prior to baseline. The washout period will be 3 days for most ADHD stimulant...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Females of child-bearing potential must have a negative pregnancy test.
• • 2. Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
• • 3. Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
• • 4. The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
• • 5. The subject and subject's parent or legal guardian must be willing and able to comply with all the testing and dosing requirements in this study.
• • 6. Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
• • 7. All subjects and their parents must be able to communicate effectively in English with the doctor and his/her staff without the aid of an interpreter.
• Exclusion Criteria:
• • 1. Subject has any documented, current, controlled psychiatric illness \[except Oppositional Defiant Disorder (ODD)\]. The child may continue participating in a behavior modification program during this study as long as he/she has been participating in the program for at least one month at the time of the baseline visit.
• • 2. Subject has Conduct Disorder (CD).
• • 3. Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
• • 4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
• • 5. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
• • 6. Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
• • 7. Subject has a history of heart abnormalities that the study doctor feels would exclude him/her from the study.
• • 8. Subject has a positive urine drug result at the screening visit.
• • 9. Subject weighs less than 50 pounds (22.7 kg).
• • 10. Subject has taken another investigational drug within the last 30 days prior to the screening visit.
• • 11. Subject has any reported history of abnormal thyroid function.
• • 12. Subject has any clinically significant electrocardiogram reading (an electrical recording of the heart - ECG) or laboratory abnormalities at the screening and/or baseline visits.
• • 13. The study doctor feels that the subject's safety would be jeopardized if entered in this study due to a current illness or medical condition. Mild, stable asthma is not exclusionary.
• • 14. Subject is taking any medication that is excluded.