Status:
COMPLETED
Melatonin Treatment for Induced Transient Insomnia
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Delayed Sleep Phase Disorder
Jet-lag
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief Summary
Melatonin supplements have been reported to be an effective treatment for circadian rhythm sleep disorders, including shift work dyssomnia, jet-lag, delayed sleep phase syndrome, and sleep disruption ...
Detailed Description
This study uses a randomized, double-blind, placebo-controlled, parallel groups design. The independent variable will be melatonin treatment group (0.3 mg melatonin, 3.0 mg melatonin, or placebo). Day...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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 in the last 3 years;
- Transmeridian travel (2 or more time zones) in past 3 months;
- Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00950885
Start Date
September 1 2009
End Date
August 1 2013
Last Update
March 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115