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Sponsors and Collaborators: |
University of Alabama at Birmingham Takeda Global Research & Development Center, Inc. |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00622427 |
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.
Condition | Intervention | Phase |
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ADHD With Sleep Onset Insomnia |
Drug: ramelteon or placebo Drug: ramelteon |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia |
Estimated Enrollment: | 40 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: ramelteon
8 mg nightly for 2 weeks
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2: Placebo Comparator
Active vs placebo, crossover
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Drug: ramelteon or placebo
8 mg or placebo tablets every night for 2 weeks, then a 2 week washout,then crossover to 8 mg tablets or placebo for 2 weeks.
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Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberta S. May, MA | 205-934-2484 | rmay@uabmc.edu |
Contact: Rakesha Garner, BS | 205-934-9189 | rgarner@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35205 |
Responsible Party: | University of Alabama at Birmingham ( Rachel Fargason, M.D. ) |
Study ID Numbers: | F071204001 |
Study First Received: | February 13, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622427 |
Health Authority: | United States: Institutional Review Board |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |