Ramelteon Night Shift Study - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	Takeda Global Research & Development Center, Inc.
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00595075

Purpose

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:

ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap;
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
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.

Condition	Intervention
Healthy	Drug: Ramelteon Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effects of Ramelteon on Sleep and Neurobehavioral Performance in a Simulated Night Shift Preceded by a Sleep Opportunity

Resource links provided by NLM:

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Sleep efficiency [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Neurobehavioral performance battery [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	December 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ramelteon 8mg will be given prior to a 2-hour nap	Drug: Ramelteon Ramelteon 8mg tablet by mouth x 1 dose
2: Placebo Comparator Placebo will be given prior to a 2-hour nap	Drug: placebo placebo identical in appearance to active experimental drug

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595075

Sponsors and Collaborators

Brigham and Women's Hospital

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:	Shantha Rajaratnam, PhD	Brigham and Women's Hosptial
Principal Investigator:	Elizabeth B Klerman, MD,PhD	Brigham and Women's Hospital

More Information

Additional Information:

Harvard Division of Sleep Medicine website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Elizabeth Klerman, MD, PhD/Shantha Rajaratnam, PhD )
Study ID Numbers:	Takeda - 103113
Study First Received:	January 7, 2008
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00595075 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

sleep
performance
night shift
Ramelteon
Healthy Individuals

ClinicalTrials.gov processed this record on March 18, 2010