Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD With Sleep Onset Insomnia
Intervention: ramelteon or placebo (Drug); ramelteon (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Alabama at Birmingham Overall contact:
Roberta S. May, MA, Phone: 205-934-2484, Email: rmay@uabmc.edu
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.
Clinical Details
Official title: Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: ADHD Rating Scale
Secondary outcome: CGI
Detailed description:
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in
adult ADHD subjects who suffer from initial insomnia.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Roberta S. May, MA, Phone: 205-934-2484, Email: rmay@uabmc.edu
University of Alabama at Birmingham, Birmingham, Alabama 35205, United States
Additional Information
Starting date: February 2008
Ending date: February 2010
Last updated: February 22, 2008
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