Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
1 other identifier
interventional
32
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 13, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 24, 2013
CompletedMay 24, 2013
April 1, 2013
2 years
February 13, 2008
June 5, 2012
April 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Baseline to 2 Weeks ADHD Rating Scale
It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.
day 1 to day 14 of study drug
Secondary Outcomes (1)
Change in Clinical Global Impression (CGI)
day 1 to day 14 of study drug
Study Arms (2)
Ramelteon then placebo
EXPERIMENTAL8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.
Placebo then Ramelteon
EXPERIMENTALplacebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of ADHD and insomnia-
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Takedacollaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Rachel Fargason
- Organization
- University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professosr
Study Record Dates
First Submitted
February 13, 2008
First Posted
February 25, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2010
Study Completion
December 1, 2010
Last Updated
May 24, 2013
Results First Posted
May 24, 2013
Record last verified: 2013-04