Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
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|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.
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): NCT00622427
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35205|