Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Completed · Phase 4 · Has a placebo group

Conditions studied: ADHD With Sleep Onset Insomnia

In brief

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.

Key facts

Study ID

NCT00622427

Run by

University of Alabama at Birmingham

People needed

32

Starts

2008-02-01

Expected to finish

2010-12-01

Last updated by the study team

2013-05-24

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of ADHD and insomnia-
• 19-65 years of age
• In good general health
• Negative pregnancy test

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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