NCT01156051

Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Children's Specialized Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder
• Attention Deficit Disorder
• Insomnia
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	Guanfacine extended-release tablets	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
DRUG	Placebo comparator	Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-07-02
• Last updated: 2014-08-11
• Results posted: 2014-08-11

Locations

2 sites across 1 country: United States