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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
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Kimberley Lakes, University of California, Irvine

Brief Summary:
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 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
Masking: Single
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vyvanse Treatment
All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication.
Drug: Vyvanse
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



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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

Publications of Results:
Responsible Party: Kimberley Lakes, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00733356     History of Changes
Other Study ID Numbers: VBHR
First Posted: August 13, 2008    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents