Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Timeline

Start

2006-09

Primary completion

2008-04

Completion

2008-07

Publications

• Background Avery DH, Eder DN, Bolte MA, Hellekson CJ, Dunner DL, Vitiello MV, Prinz PN. Dawn simulation and bright light in the treatment of SAD: a controlled study. Biol Psychiatry. 2001 Aug 1;50(3):205-16. doi: 10.1016/s0006-3223(01)01200-8.
• Background Biggs JT, Wylie LT, Ziegler VE. Validity of the Zung Self-rating Depression Scale. Br J Psychiatry. 1978 Apr;132:381-5. doi: 10.1192/bjp.132.4.381.
• Background Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Background Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.
• Background Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
• Background Dubocovich ML, Rivera-Bermudez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003 Sep 1;8:d1093-108. doi: 10.2741/1089.
• Background Gentili A, Weiner DK, Kuchibhatla M, Edinger JD. Test-retest reliability of the Pittsburgh sleep quality index in nursing home residents. J Am Geriatr Soc. 1995 Nov;43(11):1317-8. doi: 10.1111/j.1532-5415.1995.tb07415.x. No abstract available.
• Background Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
• Background Hellpach, W.H. (1911). Die geopsychischen erschelnungen; Wetter und klima und landschaft in ihrem einfluss auf das seelenleben. Leipzig: W. Engelmann.
• Background Jenner FA. Chronobiology and the clinical psychiatrist: the current position. Chronobiologia. 1974 Apr-Jun;1(2):151-60. No abstract available.
• Background Lam RW, Gorman CP, Michalon M, Steiner M, Levitt AJ, Corral MR, Watson GD, Morehouse RL, Tam W, Joffe RT. Multicenter, placebo-controlled study of fluoxetine in seasonal affective disorder. Am J Psychiatry. 1995 Dec;152(12):1765-70. doi: 10.1176/ajp.152.12.1765.
• Background Levitt AJ, Lam RW, Levitan R. A comparison of open treatment of seasonal major and minor depression with light therapy. J Affect Disord. 2002 Sep;71(1-3):243-8. doi: 10.1016/s0165-0327(01)00397-4.
• Background Lewy AJ, Sack RL. The phase-shift hypothesis of seasonal affective disorder. Am J Psychiatry. 1988 Aug;145(8):1041-3. doi: 10.1176/ajp.145.8.1041c. No abstract available.
• Background Lewy AJ, Lefler BJ, Emens JS, Bauer VK. The circadian basis of winter depression. Proc Natl Acad Sci U S A. 2006 May 9;103(19):7414-9. doi: 10.1073/pnas.0602425103. Epub 2006 Apr 28.
• Background Liu C, Weaver DR, Jin X, Shearman LP, Pieschl RL, Gribkoff VK, Reppert SM. Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron. 1997 Jul;19(1):91-102. doi: 10.1016/s0896-6273(00)80350-5.
• Background Manber R, Blasey C, Arnow B, Markowitz JC, Thase ME, Rush AJ, Dowling F, Koscis J, Trivedi M, Keller MB. Assessing insomnia severity in depression: comparison of depression rating scales and sleep diaries. J Psychiatr Res. 2005 Sep;39(5):481-8. doi: 10.1016/j.jpsychires.2004.12.003. Epub 2005 Jan 23.
• Background McClung CA. Circadian genes, rhythms and the biology of mood disorders. Pharmacol Ther. 2007 May;114(2):222-32. doi: 10.1016/j.pharmthera.2007.02.003. Epub 2007 Feb 28.
• Background Michalak EE, Wilkinson C, Dowrick C, Wilkinson G. Seasonal affective disorder: prevalence, detection and current treatment in North Wales. Br J Psychiatry. 2001 Jul;179:31-4. doi: 10.1192/bjp.179.1.31.
• Background Michalak EE, Murray G, Levitt AJ, Levitan RD, Enns MW, Morehouse R, Tam EM, Cheung A, Lam RW. Quality of life as an outcome indicator in patients with seasonal affective disorder: results from the Can-SAD study. Psychol Med. 2007 May;37(5):727-36. doi: 10.1017/S0033291706009378. Epub 2006 Nov 20.
• Background Modell JG, Rosenthal NE, Harriett AE, Krishen A, Asgharian A, Foster VJ, Metz A, Rockett CB, Wightman DS. Seasonal affective disorder and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry. 2005 Oct 15;58(8):658-67. doi: 10.1016/j.biopsych.2005.07.021.
• Background Moscovitch A, Blashko CA, Eagles JM, Darcourt G, Thompson C, Kasper S, Lane RM; International Collaborative Group on Sertraline in the Treatment of Outpatients with Seasonal Affective Disorders. A placebo-controlled study of sertraline in the treatment of outpatients with seasonal affective disorder. Psychopharmacology (Berl). 2004 Feb;171(4):390-7. doi: 10.1007/s00213-003-1594-8. Epub 2003 Sep 19.
• Background Pjrek E, Winkler D, Kasper S. Pharmacotherapy of seasonal affective disorder. CNS Spectr. 2005 Aug;10(8):664-9; quiz 672. doi: 10.1017/s1092852900019623.
• Background Postolache TT, Oren DA. Circadian phase shifting, alerting, and antidepressant effects of bright light treatment. Clin Sports Med. 2005 Apr;24(2):381-413, xii. doi: 10.1016/j.csm.2004.12.005.
• Background Praschak-Rieder N, Willeit M, Wilson AA, Houle S, Meyer JH. Seasonal variation in human brain serotonin transporter binding. Arch Gen Psychiatry. 2008 Sep;65(9):1072-8. doi: 10.1001/archpsyc.65.9.1072.
• Background Rohan KJ, Roecklein KA, Tierney Lindsey K, Johnson LG, Lippy RD, Lacy TJ, Barton FB. A randomized controlled trial of cognitive-behavioral therapy, light therapy, and their combination for seasonal affective disorder. J Consult Clin Psychol. 2007 Jun;75(3):489-500. doi: 10.1037/0022-006X.75.3.489.
• Background Rosenthal NE, Sack DA, Gillin JC, Lewy AJ, Goodwin FK, Davenport Y, Mueller PS, Newsome DA, Wehr TA. Seasonal affective disorder. A description of the syndrome and preliminary findings with light therapy. Arch Gen Psychiatry. 1984 Jan;41(1):72-80. doi: 10.1001/archpsyc.1984.01790120076010.
• Background Ruhrmann S, Kasper S, Hawellek B, Martinez B, Hoflich G, Nickelsen T, Moller HJ. Effects of fluoxetine versus bright light in the treatment of seasonal affective disorder. Psychol Med. 1998 Jul;28(4):923-33. doi: 10.1017/s0033291798006813.
• Background Thompson, C. (2001). Evidence-based treatment. In Seasonal Affective Disorder: Practice and Research (ed. T. Partonen and A. Magnusson), 151-158. New York: Oxford University Press.
• Background Thurber S, Snow M, Honts CR. The Zung Self-Rating Depression Scale: convergent validity and diagnostic discrimination. Assessment. 2002 Dec;9(4):401-5. doi: 10.1177/1073191102238471.
• Background Willeit M, Praschak-Rieder N, Neumeister A, Zill P, Leisch F, Stastny J, Hilger E, Thierry N, Konstantinidis A, Winkler D, Fuchs K, Sieghart W, Aschauer H, Ackenheil M, Bondy B, Kasper S. A polymorphism (5-HTTLPR) in the serotonin transporter promoter gene is associated with DSM-IV depression subtypes in seasonal affective disorder. Mol Psychiatry. 2003 Nov;8(11):942-6. doi: 10.1038/sj.mp.4001392.
• Background William JBW, Link MJ, Rosenthal NE, Terman M. (1988). Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders Version (SIGH-SAD). New York, New York State Psychiatric Institute
• Background ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.
• Background Zung WW. Factors influencing the self-rating depression scale. Arch Gen Psychiatry. 1967 May;16(5):543-7. doi: 10.1001/archpsyc.1967.01730230027003. No abstract available.
• Background American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American Psychiatric Association, 2000.

Drugs

Indications