Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor study identifier
interventional
24
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 2008
Actual (reported)August 2008
Actual (reported)December 9, 2008
Actual (reported)December 11, 2008
Actual (reported)Latency to Persistent Sleep (LPS) as measured by polysomnography (PSG)
performed at Baseline (Visit 2), after the subject has met all other inclusion/exclusion criteria, and at Week 7 or Early Termination
PSG sleep parameters: Wake time After Sleep Onset (WASO), Number of Awakenings After Sleep Onset (NAASO), and Total Sleep Time (TST)
within four days prior to Baseline (Visit 2), after the subject has met all other inclusion/exclusion criteria and Week 7 or Early Termination (Visit 9)
Actigraphic measures of sleep characteristics (LPS, TST)
during the week immediately preceding the following study visits: Visit 2 (Baseline), Visit 5 (Week 3), and Visit 9 (Week 7)
Pittsburgh Sleep Quality Index and Child Sleep Habits Questionnaire item scores
performed at Visits 2 through 9
Clinical Global Impression (CGI) Severity and Global Improvement item scores
each weekly visit
Conner's Parent Rating Scale - Revised (S) completed by parent/caregiver and Investigator-rated ADHD-RS-IV item scores
Visits 2 through 9
30, 50, or 70 mg
Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
John M Giblin, MD
Clinical Study Centers, LLC
24 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2008
First Posted
December 11, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
December 11, 2008
Record last verified: 2008-12
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Source: ClinicalTrials.gov.
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