Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Takeda

Criteria

Inclusion Criteria:

• Diagnosis of ADHD and insomnia-

• 19-65 years of age

• In good general health

• Negative pregnancy test

Exclusion Criteria:

• 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