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

NCT00502320 | Completed Phase 4 Results

• 1 other identifier: 06-006R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Seasonal Affective Disorder

Keywords

Seasonal Affective Disorder; Ramelteon; Psychiatry; Randomized Controlled Trial; Hamilton Depression Rating Scale- SAD Version; Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

• Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)

  Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.

  Monthly for duration of treatment (up to 4 months)

Secondary Outcomes (2)

• Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)

  Monthly for duration of treatment (up to 4 months)

• Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)

  Monthly for duration of treatment (up to 4 months)

Study Arms (2)

Ramelteon

EXPERIMENTAL

8 mg

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

one 8 mg tablet at bed for up to 4 months

Also known as: Rozerem

Ramelteon

Placebo DRUG

one tablet at bedtime for up to 4 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18-65 yrs.
• A diagnosis of seasonal affective disorder
• A Pittsburgh Sleep Quality Index \>5
• English speaking
• Be able to sign informed consent

You may not qualify if:

• Active substance abuse
• Current psychotic symptoms
• Severe personality disorders
• Primary sleep disorders
• Severe chronic obstructive pulmonary disease (COPD)
• Prescription fluvoxamine(Luvox) use

Sponsors & Collaborators

• Lehigh Valley Hospital: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Lehigh Valley Hospital, Department of Psychiatry

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (34)

• 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.

  PMID: 11513820 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.

  PMID: 638392 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.

  PMID: 2748771 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.

  PMID: 1947597 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.

  PMID: 17683643 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.

  PMID: 12957828 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.

  PMID: 7594173 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.

  PMID: 15800134 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.

  PMID: 4617659 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.

  PMID: 8526243 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.

  PMID: 12167524 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.

  PMID: 3394867 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.

  PMID: 16648247 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.

  PMID: 9247266 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.

  PMID: 15992557 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.

  PMID: 17395264 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.

  PMID: 11435265 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.

  PMID: 17112403 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.

  PMID: 16271314 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.

  PMID: 14504682 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.

  PMID: 16041297 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.

  PMID: 15892931 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.

  PMID: 18762593 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.

  PMID: 17563165 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.

  PMID: 6581756 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.

  PMID: 9723147 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.

  PMID: 12462760 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.

  PMID: 14593433 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.

  PMID: 14221692 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.

  PMID: 4381571 BACKGROUND

• American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American Psychiatric Association, 2000.

  BACKGROUND

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Edward R. Norris, MD
• Organization: Lehigh Valley Hospital

Edward.Norris@lvh.com

610-402-5766

Study Officials

• Edward R. Norris, MD

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 6, 2009
• Results First Posted: October 5, 2009

Record last verified: 2009-10

Locations

US (1)