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Ramelteon Night Shift Study
This study has been completed.
Study NCT00595075   Information provided by Brigham and Women's Hospital
First Received: January 7, 2008   Last Updated: September 15, 2009   History of Changes

January 7, 2008
September 15, 2009
December 2007
November 2008   (final data collection date for primary outcome measure)
  • Sleep efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Neurobehavioral performance battery [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00595075 on ClinicalTrials.gov Archive Site
 
 
 
Ramelteon Night Shift Study
Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity

Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses:

  1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
  2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and
  3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.
 
 
Interventional
Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Healthy
  • Drug: Ramelteon
  • Drug: placebo
  • Experimental: Ramelteon 8mg will be given prior to a 2-hour nap
  • Placebo Comparator: Placebo will be given prior to a 2-hour nap
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged between 18-35 years;
  • Non-smoking for at least 6 months;
  • Healthy (no medical, psychiatric or sleep disorders);
  • No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
  • Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
  • Body mass index of > 18 or < 30 kg/m2;
  • No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
  • Habitual caffeine consumption < 300mg per day on average;
  • Habitual alcohol consumption < 10 alcoholic units per week on average.

Exclusion Criteria:

  • History of alcohol or substance abuse;
  • Positive result on drugs of abuse screening;
  • Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
  • Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
  • Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
  • History of intolerance or hypersensitivity to melatonin or melatonin agonists;
  • Pregnancy or lactation;
  • Shift work;
  • Transmeridian travel (2 or more time zones) in past 2 months;
  • Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00595075
Elizabeth Klerman, MD, PhD/Shantha Rajaratnam, PhD, Brigham and Women's Hospital
Takeda - 103113
Brigham and Women's Hospital
Takeda Global Research & Development Center, Inc.
Principal Investigator: Shantha Rajaratnam, PhD Brigham and Women's Hosptial
Principal Investigator: Elizabeth B Klerman, MD,PhD Brigham and Women's Hospital
Brigham and Women's Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP