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

NCT02638168 | Terminated Phase 4 Results

• 1 other identifier: STUDY00003056
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity; Behavioral Insomnia of Childhood

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks

Secondary Outcomes (11)

• Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy

  3 weeks

• Pittsburgh Side Effects Rating Scale

  3 weeks

• Sleep Offset

  3 weeks

• Total Sleep Time

  3 weeks

• Wake After Sleep Onset (WASO)

  3 weeks

Study Arms (2)

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

Drug: Immediate Release Methylphenidate

Placebo

PLACEBO COMPARATOR

inert placebo ingredient

Drug: Placebo

Interventions

Immediate Release Methylphenidate DRUG

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

Also known as: Generic Methylphenidate

Immediate Release Methylphenidate

Placebo DRUG

inert placebo ingredient

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Children's Miracle Network: collaborator

Study Sites (1)

Milton S Hershey Medical Center

Hershey, Pennsylvania, 17036, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Only 3 participants were randomized.

Results Point of Contact

• Title: Raman Baweja, MD, MS
• Organization: Penn State Health Milton S Hershey Medical Center

rbaweja@pennstatehealth.psu.edu

7175318134

Study Officials

• Raman Baweja, M.D., M.S.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 17, 2019
• Results First Posted: September 17, 2019

Record last verified: 2019-09

Locations

US (1)