Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
|ClinicalTrials.gov Identifier: NCT00622427|
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : May 24, 2013
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|ADHD With Sleep Onset Insomnia||Drug: Ramelteon Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||December 2010|
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
- Change in Baseline to 2 Weeks ADHD Rating Scale [ Time Frame: day 1 to day 14 of study drug ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622427
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35205|