Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Condition: Attention-Deficit/Hyperactivity Disorder; Attention Deficit Disorder; Insomnia; Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Sleep Wake Disorders; Attention Deficit Disorder with Hyperactivity
Intervention: Guanfacine extended-release tablets; Placebo comparator
Intervention description: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated; Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Intervention MeSH terms: Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; ADD; sleep disturbance

Summary:

      This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if
      guanfacine extended release is able to improve nighttime sleep in children with ADHD -
      associated insomnia while improving daytime ADHD symptoms. Male and female children with
      diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty
      staying asleep, or less than expected hours of sleep) will be recruited. After obtaining
      informed consent and assent (when appropriate) and after discontinuation of excluded
      medications, children will have evaluations of his or her sleep and evaluations confirming
      the ADHD diagnosis. Children who successfully pass screening will be enrolled into the
      double-blind, placebo-controlled, randomized investigation with 50% of participants receiving
      guanfacine extended release and 50% of participants receiving matching placebo. Using a
      flexible-dose optimization design based on ADHD symptom improvement and medication
      tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At
      the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires,
      and sleep tests will be repeated and analyzed. The medication will be weaned over the course
      of the following 3-10 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be male or female, aged 6 - 12 years with ADHD.

          2. Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment
             of ADHD with parent or subject concerns of inadequate efficacy or intolerable side
             effects, or (b) free of any other medication used to treat ADHD for at least 30 days
             at the time of the initial sleep study.

          3. Subject must have repeated difficulty with sleep initiation or persistence despite
             attempts at adequate sleep hygiene.

          4. Subject must be able to swallow tablets.

        Exclusion Criteria:

          1. Subject or parent/LAR is unable or unwilling to discontinue present medications used
             to treat ADHD.

          2. Subject has a body mass index < 5th percentile for age, using the Centers for Disease
             Control standards reported in 2000.

          3. Subject has a body weight > 176 pounds.

          4. Subject has a diagnosis of Autism or Autism Spectrum Disorder.

          5. Subject has other serious psychiatric diagnoses.

          6. Subject has a medical condition that may require treatment with an unapproved
             medication, that may cause a safety concern, or that may confound outcome results

          7. Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).

          8. Subject has a prior problem with clonidine or guanfacine.