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

NCT00733356 | Completed Phase 4 Results DMC

• 1 other identifier: VBHR
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; ADD; reading; brain hemodynamics; brain imaging; attention; Near-Infrared Spectroscopy; NIRS; MSIT

Outcome Measures

Primary Outcomes (1)

• Gray Oral Reading Rest, Fourth Edition (GORT-4)

  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.

  baseline and final day (lab school Assessments)

Study Arms (1)

Vyvanse Treatment

EXPERIMENTAL

All subjects were tested at baseline before medication and then titrated to best dose and retested on Vyvanse Medication.

Drug: Vyvanse

Interventions

Vyvanse DRUG

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.

Also known as: lisdexamfetamine dimesylate

Vyvanse Treatment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subject is taking any medication that is excluded.

Sponsors & Collaborators

• Kimberley Lakes: lead
• Shire: collaborator

Study Sites (1)

University of California, Irvine Child Development Center

Irvine, California, 92697, United States

Location

Related Publications (1)

• Wigal SB, Maltas S, Crinella F, Stehli A, Steinhoff K, Lakes K, Schuck S. Reading performance as a function of treatment with lisdexamfetamine dimesylate in elementary school children diagnosed with ADHD. J Atten Disord. 2012 Jan;16(1):23-33. doi: 10.1177/1087054710378008. Epub 2010 Oct 26.

  PMID: 20978273 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

This is a small sample of well characterized children with ADHD who were only treated for 1 month. In addition, we did not select for children with reading disability.

Results Point of Contact

• Title: Kinberley Lakes
• Organization: University of California Irvine Child Development Center

klakes@uci.edu

949-824-3009

Study Officials

• Kimberley Lakes, PhD

  UC Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)