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| ID | Type | Description | Link |
|---|---|---|---|
| Studynumber:TAK-375/EC103 | |||
| EudraCT Number 2005-005553-22 |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon 8 mg | Drug | |||
| Zopiclone 7.5 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car. | ||
| Standard Deviation of Speed (SDS) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Speed (MS) | ||
| Mean Lateral Position (MLP) | ||
| Word Learning test:Immediate recall, Delayed Recall, Recognition time & score |
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Inclusion Criteria:
Exclusion Criteria:
5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.
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| Name | Affiliation | Role |
|---|---|---|
| Joris Verster, PhD | Utrecht Institute for Pharmaceutical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Utrecht Institute for Pharmaceutical Sciences | Utrecht | Utrecht | 3584CA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21966064 | Derived | Mets MA, de Vries JM, de Senerpont Domis LM, Volkerts ER, Olivier B, Verster JC. Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep. 2011 Oct 1;34(10):1327-34. doi: 10.5665/SLEEP.1272. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
| C515050 | zopiclone |
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| Sternberg memory scanning test: reaction time and % errors |
| Tracking task: RMS (tracking error) |
| Divided attention test: RMS,reaction time and % errors |
| DSST: number of copied symbols |
| D001523 |
| Mental Disorders |