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

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ClinicalTrials.gov Identifier: NCT02638168
Recruitment Status : Terminated (challenge in recruitment)
First Posted : December 23, 2015
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
Raman Baweja, Milton S. Hershey Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral Insomnia of Childhood Drug: Immediate Release Methylphenidate Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


Arm Intervention/treatment
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 Name: Generic Methylphenidate

Placebo Comparator: Placebo
inert placebo ingredient
Drug: Placebo
inert placebo ingredient




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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. Sleep Offset [ Time Frame: 3 weeks ]
  4. Total Sleep Time [ Time Frame: 3 weeks ]
  5. Wake After Sleep Onset (WASO) [ Time Frame: 3 weeks ]
  6. Sleep Efficiency [ Time Frame: 3 weeks ]
  7. Number of Wakings [ Time Frame: 3 weeks ]
  8. Length of Wakings [ Time Frame: 3 weeks ]
  9. 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.

  10. 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)

  11. 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)



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638168


Locations
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United States, Pennsylvania
Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17036
Sponsors and Collaborators
Milton S. Hershey Medical Center
Children's Miracle Network
Investigators
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Principal Investigator: Raman Baweja, M.D., M.S. Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Raman Baweja, Milton S. Hershey Medical Center:

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Responsible Party: Raman Baweja, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02638168     History of Changes
Other Study ID Numbers: STUDY00003056
First Posted: December 23, 2015    Key Record Dates
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Methylphenidate
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents