A Phase 1 interventional study of Ramelteon 8 mg and Zopiclone 7.5 mg in Insomnia, sponsored by Utrecht Institute for Pharmaceutical Sciences. Completed at 1 site in Netherlands. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-25.
Sponsored by Utrecht Institute for Pharmaceutical Sciences · Phase 1, Interventional, and Prevention
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Utrecht Institute for Pharmaceutical Sciences is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
Standard Deviation of Speed (SDS)
Mean Speed (MS)
Mean Lateral Position (MLP)
Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
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
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Ramelteon · Zopiclone
Sleep Initiation and Maintenance Disorders →
Utrecht Institute for Pharmaceutical Sciences