Status:
COMPLETED
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Takeda
Conditions:
ADHD With Sleep Onset Insomnia
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
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. Second...
Detailed Description
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
Eligibility Criteria
Inclusion
- Diagnosis of ADHD and insomnia-
- 19-65 years of age
- In good general health
- Negative pregnancy test
Exclusion
- Current primary psychiatric diagnosis other than ADHD
- Positive urine drug screen for any sedative hypnotic or drugs of abuse
- Unstable medical condition
- HIV positive
- Seizure disorder
- Known hypersensitivity to Ramelteon
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00622427
Start Date
February 1 2008
End Date
December 1 2010
Last Update
May 24 2013
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205