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

NCT00807222 | Completed

• 1 other identifier: IST-NRP104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ADHD; Vyvanse; lisdexamfetamine dimesylate; LDX; sleep

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

lisdexamfetamine dimesylate

ACTIVE COMPARATOR

30, 50, or 70 mg

Drug: lisdexamfetamine dimesylate

placebo

PLACEBO COMPARATOR

Drug: lisdexamfetamine dimesylate

Interventions

lisdexamfetamine dimesylate DRUG

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

Also known as: Vyvanse

lisdexamfetamine dimesylate; placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 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).

Sponsors & Collaborators

• Clinical Study Centers, LLC: lead
• Shire: collaborator

Study Sites (1)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• John M Giblin, MD

  Clinical Study Centers, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 11, 2008

Record last verified: 2008-12

Locations

US (1)