Attention Deficit Disorder With HyperactivityPhase 4NCT02638168
Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD
A Phase 4 study testing Immediate Release Methylphenidate in people with Attention Deficit Disorder With Hyperactivity and Behavioral Insomnia of Childhood, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Behavioral Insomnia of Childhood
- What is being tested?
- Immediate Release Methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 6-12 (inclusive), and able to swallow capsule
- Children who have been treated with a stable morning dose of Extended Release Methylphenidate or twice daily dose of Immediate Release Methylphenidate for an extended period of time (30 days or longer).
- DSM V diagnosis of Attention Deficit Hyperactivity Disorder (ADHD): Diagnosis will be assessed on the NIMH Computerized Diagnostic Interview Schedule for Children (C-DISC), and parent and teacher rating scales.
- Children with any ADHD subtype meeting the above criteria will be eligible, although, it is expected that the majority will be of the combined subtype of ADHD given the associate between this subtype and ODD symptoms. A diagnosis of any of the two Behavioral Insomnia of Childhood (BIC) subtypes associated with delayed SOL (limit setting or combined type) will be required.
- Sex: male or female
- Fluent in written and spoken English.
Who cannot join
- Age < 6 years of age or >12 years of age.
- Children who have not had Methylphenidate (Extended Release) treatment for an extended period of time (30 days or longer).
- A diagnosis or suspicion of sleep-disordered breathing will be exclusionary as it is not expected to be impacted by Immediate Release Methylphenidate treatment.
- Current psychotropics other than Methylphenidate (Extended Release or Immediate Release Methylphenidate). Children prescribed alpha agonists for adjunctive control of ADHD in combination with a MPH product will be allowed to enroll as long as they meet all other entry criteria (i.e. sleep must remained impaired with use of alpha agonist).
- Regular use of other medications that impact sleep within the last 14 days (i.e.: sedating antihistamines, melatonin).
- Active medical/psychiatric conditions that impact sleep (i.e.: severe asthma, Autism Spectrum Disorder diagnosis, marked developmental delay, or mood/anxiety disorder).
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17036
About this study
Official title: Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With Attention Deficit Hyperactivity Disorder: A Randomized Placebo-controlled Pilot Study
Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes; alternate medications have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive behaviors could improve sleep patterns and this application will assess if the extension of the therapeutic effects of CNS stimulants into the early evening improves sleep onset.
Read the detailed description
The goal of this application is to assess the impact of safer treatment option Methylphenidate (MPH) on sleep and behavior problems in children with Attention Deficit Hyperactivity Disorder (ADHD) and Behavioral Insomnia of Childhood (BIC). ADHD affects over 11% of school-aged youth. Similarly, pediatric sleep disorders occur in over a third of children and impact multiple domains of the child's functioning as well as that of their parents. Children with ADHD are at an increased risk for sleep problems with a staggering comorbidity of up to 70%, while sleep deprivation worsens the already impaired social, emotional and academic functioning of children with ADHD. Therefore, improving sleep may translate into enhanced functioning in multiple realms. Delayed sleep onset latency (SOL) and bedtime resistance, the key component of the limit setting type of BIC, are particularly likely to occur in children with ADHD. Medications are commonly used for both conditions with over 6% of all school-aged children in the United States prescribed medication for ADHD and 7% for sleep. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes. Alternate medications for sleep have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. MPH has an extensive database supporting their safety and efficacy. Objective sleep studies of MPH have not found consistent results, with a few studies reporting delayed SOL and while others report improved quality of sleep. Therefore, this proposal will evaluate the impact of extending MPH treatment into the early evening on sleep onset using a 3-week with-in subjects randomized trial of .3mg/kg of immediate release (IR) MPH dosed 3 hours before bedtime vs. placebo in 38 children with ADHD and chronically delayed SOL who have a history of prolonged stimulant usage. The investigators will recruit 38 children ages 6-12 of any gender and racial/ethnic status with ADHD who have been treated with stable morning dose of extended release (ER) MPH for an extended time period (30 days or more) from the primary care and psychiatry clinics at Hershey Medical Center in Hershey, PA. Recruitment will be split into three waves (13, 13, 12 participants). Parents will be reminded to administer the blinded medication dose by text message each evening (or phone call by study staff) 3 hours prior to the desired bedtime. Sleep onset will be measured by actigraphy and sleep log, with parents also reporting on level of ODD and ADHD symptoms in the evening.
- Being tested
- Immediate Release Methylphenidate, Placebo
- 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.
Immediate Release MethylphenidateDrug
Also called Generic Methylphenidate
The medication assessment procedure will be a double-blind, within-subject evaluation of placebo and matching evening dose of IR MPH rounded to the nearest 2.5mg increment with a max IR MPH dose of 0.3mg/kg. Expected evening dose range will be from 2.5mg to 20mg with most participants receiving between 5 to 15mg per evening dose. Dose will be determined based on current dose of their morning extended release stimulant
PlaceboDrug
inert placebo ingredient
| Study group | Role | What they receive |
|---|---|---|
| Immediate Release Methylphenidate | Active comparator | With-in subjects trial. Subjects will be randomized to 0.3 mg/kg of Immediate Release Methylphenidate versus placebo over 3-weeks duration Receives: Drug: Immediate Release Methylphenidate |
| Placebo | Placebo comparator | inert placebo ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log
Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log
Measured: 3 weeks
Secondary outcomes (11)
Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy
Sleep onset latency is defines as duration of time in bed until sleep actigraphy
Measured: 3 weeks
Pittsburgh Side Effects Rating Scale
Pittsburgh Side Effects Rating Scale to evaluate adverse reactions to Methylphenidate Higher scores mean a worse outcome (more side effects with medication) This scales has 13 items, which are reported as None (0), Mild (1), Moderate (2) and Severe (3) Total score is calculated by summiting all items. Total Score Ranges (0-39)
Measured: 3 weeks
Sleep Offset
Measured: 3 weeks
Total Sleep Time
Measured: 3 weeks
Wake After Sleep Onset (WASO)
Measured: 3 weeks
Sleep Efficiency
Measured: 3 weeks
Number of Wakings
Measured: 3 weeks
Length of Wakings
Measured: 3 weeks
Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy
We calculated Night to night variability by the difference between the mean sleep onset latency during the weekend days and the mean sleep onset latency during the weekdays.
Measured: 3 weeks
Parent Rated 10-item IOWA
Higher scores mean severe symptoms This scales has 10 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-30)
Measured: 3 weeks
Affective Reactivity Index (ARI)
Higher scores mean a worse symptoms This scales has 7 items, which are reported as Not true (0), somewhat true (1) certainly true (2) Total score is calculated by summiting all items. Total Score Ranges (0-14)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: challenge in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Principal investigator, Raman Baweja, Milton S. Hershey Medical Center
- Investigators
- Raman Baweja, M.D., M.S., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638168
- Sponsor's protocol ID
- STUDY00003056
- Status last verified
- Sep 2019
- First submitted
- 15 Dec 2015
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With Attention Deficit Hyperactivity Disorder: A Randomized Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02638168
- Acronym / sponsor ID
- STUDY00003056
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: challenge in recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes; alternate medications have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive behaviors could improve sleep patterns and this application will assess if the extension of the therapeutic effects of CNS stimulants into the early evening improves sleep onset.
Detailed description
The goal of this application is to assess the impact of safer treatment option Methylphenidate (MPH) on sleep and behavior problems in children with Attention Deficit Hyperactivity Disorder (ADHD) and Behavioral Insomnia of Childhood (BIC). ADHD affects over 11% of school-aged youth. Similarly, pediatric sleep disorders occur in over a third of children and impact multiple domains of the child's functioning as well as that of their parents. Children with ADHD are at an increased risk for sleep problems with a staggering comorbidity of up to 70%, while sleep deprivation worsens the already impaired social, emotional and academic functioning of children with ADHD. Therefore, improving sleep may translate into enhanced functioning in multiple realms. Delayed sleep onset latency (SOL) and bedtime resistance, the key component of the limit setting type of BIC, are particularly likely to occur in children with ADHD. Medications are commonly used for both conditions with over 6% of all school-aged children in the United States prescribed medication for ADHD and 7% for sleep. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes. Alternate medications for sleep have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. MPH has an extensive database supporting their safety and efficacy. Objective sleep studies of MPH have not found consistent results, with a few studies reporting delayed SOL and while others report improved quality of sleep. Therefore, this proposal will evaluate the impact of extending MPH treatment into the early evening on sleep onset using a 3-week with-in subjects randomized trial of .3mg/kg of immediate release (IR) MPH dosed 3 hours before bedtime vs. placebo in 38 children with ADHD and chronically delayed SOL who have a history of prolonged stimulant usage. The investigators will recruit 38 children ages 6-12 of any gender and racial/ethnic status with ADHD who have been treated with stable morning dose of extended release (ER) MPH for an extended time period (30 days or more) from the primary care and psychiatry clinics at Hershey Medical Center in Hershey, PA. Recruitment will be split into three waves (13, 13, 12 participants). Parents will be reminded to administer the blinded medication dose by text message each evening (or phone call by study staff) 3 hours prior to the desired bedtime. Sleep onset will be measured by actigraphy and sleep log, with parents also reporting on level of ODD and ADHD symptoms in the evening.
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 |
|---|---|---|
| Immediate Release Methylphenidate | Active comparator | Drug: Immediate Release MethylphenidateWith-in subjects trial. Subjects will be randomized to 0.3 mg/kg of Immediate Release Methylphenidate versus placebo over 3-weeks duration |
| Placebo | Placebo comparator | Drug: Placeboinert placebo ingredient |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 6-12 (inclusive), and able to swallow capsule
- Children who have been treated with a stable morning dose of Extended Release Methylphenidate or twice daily dose of Immediate Release Methylphenidate for an extended period of time (30 days or longer).
- DSM V diagnosis of Attention Deficit Hyperactivity Disorder (ADHD): Diagnosis will be assessed on the NIMH Computerized Diagnostic Interview Schedule for Children (C-DISC), and parent and teacher rating scales.
- Children with any ADHD subtype meeting the above criteria will be eligible, although, it is expected that the majority will be of the combined subtype of ADHD given the associate between this subtype and ODD symptoms. A diagnosis of any of the two Behavioral Insomnia of Childhood (BIC) subtypes associated with delayed SOL (limit setting or combined type) will be required.
- Sex: male or female
Key exclusion criteria (6 listed)
- Age < 6 years of age or >12 years of age.
- Children who have not had Methylphenidate (Extended Release) treatment for an extended period of time (30 days or longer).
- A diagnosis or suspicion of sleep-disordered breathing will be exclusionary as it is not expected to be impacted by Immediate Release Methylphenidate treatment.
- Current psychotropics other than Methylphenidate (Extended Release or Immediate Release Methylphenidate). Children prescribed alpha agonists for adjunctive control of ADHD in combination with a MPH product will be allowed to enroll as long as they meet all other entry criteria (i.e. sleep must remained impaired with use of alpha agonist).
- Regular use of other medications that impact sleep within the last 14 days (i.e.: sedating antihistamines, melatonin).
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 |
|---|---|---|
| Immediate Release MethylphenidateAlso: Generic MethylphenidateThe medication assessment procedure will be a double-blind, within-subject evaluation of placebo and matching evening dose of IR MPH rounded to the nearest 2.5mg increment with a max IR MPH dose of 0.3mg/kg. Expected evening dose range will be from 2.5mg to 20mg with most participants receiving between 5 to 15mg per evening dose. Dose will be determined based on current dose of their morning extended release stimulant | Drug | Immediate Release Methylphenidate |
| Placeboinert placebo ingredient | Drug | Placebo |
Primary outcome
Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log
Time frame: 3 weeks
Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log
11 secondary outcomes
Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy
Time frame: 3 weeks
Pittsburgh Side Effects Rating Scale
Time frame: 3 weeks
Sleep Offset
Time frame: 3 weeks
Total Sleep Time
Time frame: 3 weeks
Wake After Sleep Onset (WASO)
Time frame: 3 weeks
Sleep Efficiency
Time frame: 3 weeks
Number of Wakings
Time frame: 3 weeks
Length of Wakings
Time frame: 3 weeks
Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy
Time frame: 3 weeks
Parent Rated 10-item IOWA
Time frame: 3 weeks
Affective Reactivity Index (ARI)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raman Baweja, M.D., M.S. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate Release Methylphenidate in people with Attention Deficit Disorder With Hyperactivity and Behavioral Insomnia of Childhood, run by Milton S. Hershey Medical Center 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Sep 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log (time frame: 3 weeks). 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 17 Sep 2019.