The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading (VBHR)
This study has been completed.
Sponsor:
University of California, Irvine
Collaborator:
Shire Development LLC
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Females of child-bearing potential must have a negative pregnancy test.
- Subjects must meet DSM-IV-TR™ criteria for a primary diagnosis of ADHD.
- Subjects must have an ADHDRS-IV-Parent: Inv total score at least 1.5 standard deviations above the age and gender norms.
- The subject is functioning at an age appropriate level intellectually as determined by an IQ score of ≥ 80 on the Kaufman Brief Intelligence Test.
- 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.
- Subject has blood pressure measurements within the 95th percentile for age, gender, and height.
- 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:
- 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.
- Subject has Conduct Disorder (CD).
- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines, which is the class of drug to which Vyvanse™ belongs.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
- 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.
- Subject has a history of heart abnormalities that the study doctor feels would exclude him/her from the study.
- Subject has a positive urine drug result at the screening visit.
- Subject weighs less than 50 pounds (22.7 kg).
- Subject has taken another investigational drug within the last 30 days prior to the screening visit.
- Subject has any reported history of abnormal thyroid function.
- Subject has any clinically significant electrocardiogram reading (an electrical recording of the heart - ECG) or laboratory abnormalities at the screening and/or baseline visits.
- 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.
- 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 Development LLC
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:
|
Attention Deficit Hyperactivity Disorder ADHD ADD reading brain hemodynamics brain imaging |
attention Reading 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 May 16, 2013