Back to resultsEffect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine dimesylate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Vyvanse, lisdexamfetamine dimesylate, LDX, sleep
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- Clinical Study Centers, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
lisdexamfetamine dimesylate
placebo
Arm Description
30, 50, or 70 mg
Outcomes
Primary Outcome Measures
Latency to Persistent Sleep (LPS) as measured by polysomnography (PSG)
Secondary Outcome Measures
PSG sleep parameters: Wake time After Sleep Onset (WASO), Number of Awakenings After Sleep Onset (NAASO), and Total Sleep Time (TST)
Actigraphic measures of sleep characteristics (LPS, TST)
Pittsburgh Sleep Quality Index and Child Sleep Habits Questionnaire item scores
Clinical Global Impression (CGI) Severity and Global Improvement item scores
Conner's Parent Rating Scale - Revised (S) completed by parent/caregiver and Investigator-rated ADHD-RS-IV item scores
Full Information
NCT ID
NCT00807222
First Posted
December 9, 2008
Last Updated
December 10, 2008
Sponsor
Clinical Study Centers, LLC
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT00807222
Brief Title
Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Clinical Study Centers, LLC
Collaborators
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Sleep
Keywords
ADHD, Vyvanse, lisdexamfetamine dimesylate, LDX, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lisdexamfetamine dimesylate
Arm Type
Active Comparator
Arm Description
30, 50, or 70 mg
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine dimesylate
Other Intervention Name(s)
Vyvanse
Intervention Description
Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Pittsburgh Sleep Quality Index and Child Sleep Habits Questionnaire item scores
Time Frame
performed at Visits 2 through 9
Title
Clinical Global Impression (CGI) Severity and Global Improvement item scores
Time Frame
each weekly visit
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Giblin, MD
Organizational Affiliation
Clinical Study Centers, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
We'll reach out to this number within 24 hrs