Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia|
- Change in Baseline to 2 Weeks ADHD Rating Scale [ Time Frame: day 1 to day 14 of study drug ] [ Designated as safety issue: No ]It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
- Change in Clinical Global Impression (CGI) [ Time Frame: day 1 to day 14 of study drug ] [ Designated as safety issue: No ]The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.
|Study Start Date:||February 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Ramelteon then placebo
8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
8 mg tablets every night for 2 weeks
Other Name: Rozerem
Experimental: Placebo then Ramelteon
placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
placebo tablets for every night for 2 weeks
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.