Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD
Condition: Attention Deficit Disorder With Hyperactivity; Behavioral Insomnia of Childhood
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Immediate Release Methylphenidate; Placebo
Intervention description: 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; inert placebo ingredient
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

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.
    

Eligibility 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).