Effects of Ramelteon on Driving Ability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319215
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 25, 2007
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: Ramelteon 8 mg Drug: Zopiclone 7.5 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : March 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
  2. Standard Deviation of Speed (SDS)

Secondary Outcome Measures :
  1. Mean Speed (MS)
  2. Mean Lateral Position (MLP)
  3. Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
  4. Sternberg memory scanning test: reaction time and % errors
  5. Tracking task: RMS (tracking error)
  6. Divided attention test: RMS,reaction time and % errors
  7. DSST: number of copied symbols

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319215

Utrecht Institute for Pharmaceutical Sciences
Utrecht, Netherlands, 3584CA
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Principal Investigator: Joris Verster, PhD Utrecht Institute for Pharmaceutical Sciences

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00319215     History of Changes
Other Study ID Numbers: 05/316
EudraCT Number 2005-005553-22
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs