Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
|ClinicalTrials.gov Identifier: NCT01156051|
Recruitment Status : Terminated (extended beyond completion date; chose to close out rather than renew IRB review)
First Posted : July 2, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder Insomnia Sleep Disorders||Drug: Guanfacine extended-release tablets Drug: Placebo comparator||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia|
|Study Start Date :||June 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: Guanfacine Extended-Release Tablets
Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
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
Other Name: Intuniv (TM), guanfacine HCl, SPD503
Placebo Comparator: Placebo comparator
Drug: Placebo comparator
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Other Name: "sugar pill"
- Change in Polysomnographic Total Sleep Time (TST) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]Change in objective measures of sleep, using polysomnography
- Change in Baseline to Treatment ADHD-Rating Scale IV Total Score [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).
- Change in Baseline to Treatment Latency to Persistent Sleep (LPS) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]Change in an objective measure of sleep onset, using polysomnography.
- Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156051
|United States, New Jersey|
|Children's Specialized Hospital|
|Hamilton, New Jersey, United States, 08619|
|Children's Specialized Hospital|
|Toms River, New Jersey, United States, 08755|
|Principal Investigator:||Thomas A Rugino, MD||Children's Specialized Hospital|