Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD

September 16, 2019 updated by: Raman Baweja, Milton S. Hershey Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17036
        • Milton S Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 6-12 (inclusive), and able to swallow capsule
  2. 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).
  3. 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.
  4. 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.
  5. Sex: male or female
  6. Fluent in written and spoken English.

Exclusion Criteria:

  1. Age < 6 years of age or >12 years of age.
  2. Children who have not had Methylphenidate (Extended Release) treatment for an extended period of time (30 days or longer).
  3. A diagnosis or suspicion of sleep-disordered breathing will be exclusionary as it is not expected to be impacted by Immediate Release Methylphenidate treatment.
  4. 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).
  5. Regular use of other medications that impact sleep within the last 14 days (i.e.: sedating antihistamines, melatonin).
  6. Active medical/psychiatric conditions that impact sleep (i.e.: severe asthma, Autism Spectrum Disorder diagnosis, marked developmental delay, or mood/anxiety disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Immediate Release Methylphenidate
With-in subjects trial. Subjects will be randomized to 0.3 mg/kg of Immediate Release Methylphenidate versus placebo over 3-weeks duration
Drug: Immediate Release 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
Other Names:
  • Generic Methylphenidate
Placebo Comparator: Placebo
inert placebo ingredient
Drug: Placebo
inert placebo ingredient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy
Time Frame: 3 weeks
Sleep onset latency is defines as duration of time in bed until sleep actigraphy
3 weeks
Pittsburgh Side Effects Rating Scale
Time Frame: 3 weeks
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)
3 weeks
Sleep Offset
Time Frame: 3 weeks
3 weeks
Total Sleep Time
Time Frame: 3 weeks
3 weeks
Wake After Sleep Onset (WASO)
Time Frame: 3 weeks
3 weeks
Sleep Efficiency
Time Frame: 3 weeks
3 weeks
Number of Wakings
Time Frame: 3 weeks
3 weeks
Length of Wakings
Time Frame: 3 weeks
3 weeks
Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy
Time Frame: 3 weeks
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.
3 weeks
Parent Rated 10-item IOWA
Time Frame: 3 weeks
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)
3 weeks
Affective Reactivity Index (ARI)
Time Frame: 3 weeks
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)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Miracle Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raman Baweja, M.D., M.S., Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00003056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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