NCT01419938 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL
Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.
Bjorvatn B, Pallesen S
A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8. Review.
Dagan Y, Yovel I, Hallis D, Eisenstein M, Raichik I
Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). Chronobiol Int. 1998 Mar;15(2):181-90.
Gooley JJ
Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singapore. 2008 Aug;37(8):669-76. Review.

Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up

Clinical trial NCT01419938 - References