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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon then placebo | Experimental | 8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks. |
|
| Placebo then Ramelteon | Experimental | placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug | 8 mg tablets every night for 2 weeks |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
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Subjects were screened by medical and psychiatric history after responding to solicitation with advertisements in local newspapers and from existing clinic populations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon Then Placebo (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep |
| FG001 | Placebo Then Ramelteon (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon Then Placebo (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep |
| BG001 | Placebo Then Ramelteon (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of change | day 1 to day 14 of study drug |
|
Length of study--average of 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon Then Placebo (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Fargason | University of Alabama at Birmingham | 205-934-5151 | mfargason@uab.edu |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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| Placebo | Drug | placebo tablets for every night for 2 weeks |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of change | day 1 to day 14 of study drug |
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Placebo Then Ramelteon (8 mg) | QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep | 0 | 16 | 4 | 16 |
| Hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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