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

Completed · Not applicable · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder, Sleep

In brief

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.

Key facts

Study ID: NCT00807222
Run by: Clinical Study Centers, LLC
People needed: 24
Starts: 2008-04-01
Expected to finish: 2008-08-01
Last updated by the study team: 2008-12-11

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subject 6 to 12 years of age, inclusive
Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD
Female subjects of childbearing potential (FOCP) must have a negative urine pregnancy test
Subject must be in general good health
Subject's parent or legally authorized guardian provides signature of informed consent, and there is documentation of assent by the subject.
Subject and parent/caregiver are willing and able to comply with all the testing and requirements defined in the protocol.
Subject is generally functioning academically at age-appropriate levels
Subject is able to swallow a capsule.
Subject and parent/guardian are willing to comply with entire visit schedule for the study and Sleep Hygiene Instructions

You may not qualify if…

Subject has a comorbid psychiatric diagnosis that contraindicates VyvanseTM treatment or would confound efficacy or safety assessments.
Subject has any comorbid illness that could interfere with participation in the study.
Subject is a known non-responder to an adequate trial of stimulant medication for ADHD.
Subject has history of symptoms or has an identified sleep disorder
Subject has a history of seizure during the last 2 years
Subject is significantly overweight or obese
Subject has any clinically significant ECG or laboratory abnormalities at screening or baseline.
Subject has any specific cardiac condition or family history of cardiac disease
Subject is taking medications that affect blood pressure or heart rate (except current ADHD therapy, if any).
Subject has a positive urine drug result at screening (except current ADHD therapy, if any).
Subject is hypertensive.
Subject has any documented adverse reactions, allergy, or intolerance to amphetamines or dextroamphetamines.
Subject is taking exclusionary medications
Subject currently has (or had a history in the previous 12 months) a drug dependence or substance abuse disorder
Subject has taken another investigational product or taken part in a clinical trial within the 30 days prior to Screening (Visit 1).

Where it is running

Clinical Study Centers, LLC — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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