Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

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

Official Title
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Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Conditions
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ADHD With Sleep Onset Insomnia

Intervention / Treatment
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* Drug: Ramelteon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramelteon then placebo<br>8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks. | Drug: Ramelteon<br>* 8 mg tablets every night for 2 weeks<br>* Other names: Rozerem;|
| Experimental: Placebo then Ramelteon<br>placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks. | Drug: Placebo<br>* placebo tablets for every night for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression (CGI) | 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. | day 1 to day 14 of study drug |