Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT00807222
Last Updated: 2008-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2008-04-30
2008-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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lisdexamfetamine dimesylate
30, 50, or 70 mg
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.
placebo
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD
3. Female subjects of childbearing potential (FOCP) must have a negative urine pregnancy test
4. Subject must be in general good health
5. Subject's parent or legally authorized guardian provides signature of informed consent, and there is documentation of assent by the subject.
6. Subject and parent/caregiver are willing and able to comply with all the testing and requirements defined in the protocol.
7. Subject is generally functioning academically at age-appropriate levels
8. Subject is able to swallow a capsule.
9. Subject and parent/guardian are willing to comply with entire visit schedule for the study and Sleep Hygiene Instructions
Exclusion Criteria
2. Subject has any comorbid illness that could interfere with participation in the study.
3. Subject is a known non-responder to an adequate trial of stimulant medication for ADHD.
4. Subject has history of symptoms or has an identified sleep disorder
5. Subject has a history of seizure during the last 2 years
6. Subject is significantly overweight or obese
7. Subject has any clinically significant ECG or laboratory abnormalities at screening or baseline.
8. Subject has any specific cardiac condition or family history of cardiac disease
9. Subject is taking medications that affect blood pressure or heart rate (except current ADHD therapy, if any).
10. Subject has a positive urine drug result at screening (except current ADHD therapy, if any).
11. Subject is hypertensive.
12. Subject has any documented adverse reactions, allergy, or intolerance to amphetamines or dextroamphetamines.
13. Subject is taking exclusionary medications
14. Subject currently has (or had a history in the previous 12 months) a drug dependence or substance abuse disorder
15. Subject has taken another investigational product or taken part in a clinical trial within the 30 days prior to Screening (Visit 1).
6 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Clinical Study Centers, LLC
OTHER
Responsible Party
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Clinical Study Centers, LLC
Principal Investigators
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John M Giblin, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Study Centers, LLC
Locations
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Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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IST-NRP104
Identifier Type: -
Identifier Source: org_study_id