Attention Deficit Hyperactivity DisorderNCT00807222
Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder and Sleep, run by Clinical Study Centers, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Sleep
- What is being tested?
- lisdexamfetamine dimesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
About this study
Official title: Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Sleep
- Being tested
- lisdexamfetamine dimesylate
- Keywords
- ADHD, Vyvanse, lisdexamfetamine dimesylate, LDX, sleep
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lisdexamfetamine dimesylateDrug
Also called Vyvanse
Subjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks.
| Study group | Role | What they receive |
|---|---|---|
| lisdexamfetamine dimesylate | Active comparator | 30, 50, or 70 mg Receives: Drug: lisdexamfetamine dimesylate |
| placebo | Placebo comparator | Not described Receives: Drug: lisdexamfetamine dimesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Persistent Sleep (LPS) as measured by polysomnography (PSG)
Measured: 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)
Measured: 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)
Measured: 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
Measured: performed at Visits 2 through 9
Clinical Global Impression (CGI) Severity and Global Improvement item scores
Measured: each weekly visit
Conner's Parent Rating Scale - Revised (S) completed by parent/caregiver and Investigator-rated ADHD-RS-IV item scores
Measured: Visits 2 through 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Study Centers, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Investigators
- John M Giblin, MD, Principal investigator, Clinical Study Centers, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807222
- Sponsor's protocol ID
- IST-NRP104
- Status last verified
- Dec 2008
- First submitted
- 9 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Vyvanse (Lisdexamfetamine Dimesylate) on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00807222
- Acronym / sponsor ID
- IST-NRP104
- Conditions
- Attention Deficit Hyperactivity Disorder, Sleep
- Keywords
- ADHD, Vyvanse, lisdexamfetamine dimesylate, LDX, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clinical Study Centers, LLCUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lisdexamfetamine dimesylate | Active comparator | Drug: lisdexamfetamine dimesylate30, 50, or 70 mg |
| placebo | Placebo comparator | Drug: lisdexamfetamine dimesylate |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lisdexamfetamine dimesylateAlso: VyvanseSubjects will receive Vyvanse 30, 50, or 70 mg per day or placebo capsules orally for up to (a maximum of) seven (7) weeks. | Drug | lisdexamfetamine dimesylate, placebo |
Primary outcome
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
5 secondary outcomes
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)
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)
Pittsburgh Sleep Quality Index and Child Sleep Habits Questionnaire item scores
Time frame: performed at Visits 2 through 9
Clinical Global Impression (CGI) Severity and Global Improvement item scores
Time frame: each weekly visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Giblin, MD principal investigator
Clinical Study Centers, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lisdexamfetamine dimesylate in people with Attention Deficit Hyperactivity Disorder and Sleep, run by Clinical Study Centers, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.