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

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00733356
First received: August 11, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

This is a single-blind, Investigator Initiated 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 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.


Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder
Drug: Vyvanse
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To assess the effect of Vyvanse on brain hemodynamics during attention & reading tasks in children with ADHD. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vyvanse
    Subject's 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 subject's will take their prescribed dose once a day in the morning with breakfast.
    Other Name: lisdexamfetamine dimesylate
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733356

Locations
United States, California
University of California, Irvine Child Development Center
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Shire
Investigators
Principal Investigator: Kimberley Lakes, PhD UC Irvine
  More Information

Publications:
Responsible Party: Kimberley Lakes, PhD. Principal Investigator, Univeristy of California, Irvine
ClinicalTrials.gov Identifier: NCT00733356     History of Changes
Other Study ID Numbers: VBHR
Study First Received: August 11, 2008
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board
United States: Research Advisory Panel of California

Keywords provided by University of California, Irvine:
reading
Reading
Attention Deficit Hyperactivity Disorder
ADHD
ADD
brain hemodynamics
brain imaging
attention
Brain Hemodynamics
Near-Infrared Spectroscopy
NIRS
MSIT

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014