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

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by:
Clinical Study Centers, LLC
ClinicalTrials.gov Identifier:
NCT00807222
First received: December 9, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Sleep
Drug: lisdexamfetamine dimesylate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Clinical Study Centers, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index and Child Sleep Habits Questionnaire item scores [ Time Frame: performed at Visits 2 through 9 ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) Severity and Global Improvement item scores [ Time Frame: each weekly visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lisdexamfetamine dimesylate
30, 50, or 70 mg
Drug: 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 Name: Vyvanse
Placebo Comparator: placebo Drug: 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 Name: Vyvanse

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject 6 to 12 years of age, inclusive
  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:

  1. Subject has a comorbid psychiatric diagnosis that contraindicates VyvanseTM treatment or would confound efficacy or safety assessments.
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807222

Locations
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Clinical Study Centers, LLC
Shire
Investigators
Principal Investigator: John M Giblin, MD Clinical Study Centers, LLC
  More Information

No publications provided

Responsible Party: John Martin Giblin, MD / President/CEO, Medical Director, Clinical Study Centers, LLC
ClinicalTrials.gov Identifier: NCT00807222     History of Changes
Other Study ID Numbers: IST-NRP104
Study First Received: December 9, 2008
Last Updated: December 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Clinical Study Centers, LLC:
ADHD
Vyvanse
lisdexamfetamine dimesylate
LDX
sleep

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Dextroamphetamine
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014