Clinical trial NCT00319215: Effects of Ramelteon on Driving Ability
Official title: A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Keywords: ramelteon
zopiclone
driving
memory
balance
psychomotor
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2006-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. The subject is male or female, 21 - 55 years of age, inclusive
2. The subject is capable of understanding and complying with the protocol requirements.
3. The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
4. The subject, if female, is non-pregnant and non-lactating.
5. Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
6. An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.

Exclusion Criteria:

1. The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
2. The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.

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.

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
measure: Standard Deviation of Speed (SDS)
Secondary outcomes:
measure: Mean Speed (MS)
measure: Mean Lateral Position (MLP)
measure: Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
measure: Sternberg memory scanning test: reaction time and % errors
measure: Tracking task: RMS (tracking error)
measure: Divided attention test: RMS,reaction time and % errors
measure: DSST: number of copied symbols
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht Institute for Pharmaceutical Sciences
Study officials:
affiliation: Utrecht Institute for Pharmaceutical Sciences
name: Joris Verster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.