Clinical trial NCT01156051: Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Official title: Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Attention-Deficit/Hyperactivity Disorder
Attention Deficit Disorder
Insomnia
Sleep Disorders
Keywords: ADHD
ADD
sleep disturbance
Lead sponsor: Children's Specialized Hospital
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2010-07-02
Enrollment: 29
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Polysomnographic Total Sleep Time (TST)
timeFrame: Baseline to last observation carried forward (after at least one week of dose stability)
Secondary outcomes:
measure: Change in Baseline to Treatment ADHD-Rating Scale IV Total Score
timeFrame: Baseline to last observation carried forward (after at least one week of dose stability)
measure: Change in Baseline to Treatment Latency to Persistent Sleep (LPS)
timeFrame: Baseline to last observation carried forward (after at least one week of dose stability)
measure: Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)
timeFrame: Baseline to last observation carried forward (after at least one week of dose stability)
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
Study officials:
affiliation: Children's Specialized Hospital
name: Thomas A Rugino, MD
role: PRINCIPAL_INVESTIGATOR
References: