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Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00807222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-12-11

No results posted yet for this study

Summary

This study involves research to test how Vyvanse (study drug) affects sleep in 24 children aged 6 to 12 years who have ADHD. Vyvanse is approved by the FDA for the treatment ADHD of in children aged 6 to 12 years. The experimental part of this study is to determine how Vyvanse affects sleep.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • Sleep

Interventions

DRUG

lisdexamfetamine dimesylate

Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Clinical Study Centers, LLC

    lead OTHER

Principal Investigators

  • John M Giblin, MD · Clinical Study Centers, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807222 on ClinicalTrials.gov