Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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.