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.
Treatment with psychostimulants has been associated with sleep disturbances, including both sleep onset and maintenance problems, in children with ADHD. This analysis evaluated the effect of lisdexamfetamine dimesylate (LDX) on sleep in children with ADHD. This single center, double-blind, placebo-controlled, parallel-group trial enrolled children aged 6-12 years with a DSM-IV-TR diagnosis of ADHD. The study included a screening period, 1-week washout, 3-week open-label LDX dose optimization phase, and a 4-week double-blind treatment phase in which subjects were randomized to placebo or active LDX treatment at 30, 50, or 70 mg/d. Polysomnograph and actigraph measures as well as assessments of subjective sleep parameters were performed in all subjects prior to treatment and reassessed after treatment with either LDX or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Latency to Persistent Sleep (LPS) as measured by polysomnography (PSG)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: performed at Visits 2 through 9
Clinical Global Impression (CGI) Severity and Global Improvement item scores
Time frame: each weekly visit
Conner's Parent Rating Scale - Revised (S) completed by parent/caregiver and Investigator-rated ADHD-RS-IV item scores
Time frame: Visits 2 through 9
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