Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Phase 4

Completed

• Conditions: ADHD With Sleep Onset Insomnia
• Interventions: Drug: Placebo; Drug: Ramelteon

• Registration Number: NCT00622427
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2010-02
• Study Completion: 2010-12
• Results First Submitted: 2012-06-05
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Results First Posted: 2013-05-24
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo then Ramelteon	Placebo	placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
Ramelteon then placebo	Ramelteon	8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Baseline to 2 Weeks ADHD Rating Scale	day 1 to day 14 of study drug	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.

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression (CGI)	day 1 to day 14 of study drug	The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States