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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00502320
Other study ID # 06-006R
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2007
Last updated October 2, 2009
Start date September 2006
Est. completion date July 2008

Study information

Verified date October 2009
Source Lehigh Valley Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Active substance abuse

- Current psychotic symptoms

- Severe personality disorders

- Primary sleep disorders

- Severe chronic obstructive pulmonary disease (COPD)

- Prescription fluvoxamine(Luvox) use

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ramelteon
one 8 mg tablet at bed for up to 4 months
Placebo
one tablet at bedtime for up to 4 months

Locations

Country Name City State
United States Lehigh Valley Hospital, Department of Psychiatry Allentown Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Lehigh Valley Hospital Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (34)

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

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. — View Citation

Biggs JT, Wylie LT, Ziegler VE. Validity of the Zung Self-rating Depression Scale. Br J Psychiatry. 1978 Apr;132:381-5. — View Citation

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. — View Citation

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. Erratum in: Sleep 1992 Feb;15(1):83. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Hellpach, W.H. (1911). Die geopsychischen erschelnungen; Wetter und klima und landschaft in ihrem einfluss auf das seelenleben. Leipzig: W. Engelmann.

Jenner FA. Chronobiology and the clinical psychiatrist: the current position. Chronobiologia. 1974 Apr-Jun;1(2):151-60. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Apr 28. — View Citation

Lewy AJ, Sack RL. The phase-shift hypothesis of seasonal affective disorder. Am J Psychiatry. 1988 Aug;145(8):1041-3. — View Citation

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. — View Citation

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. Epub 2005 Jan 23. — View Citation

McClung CA. Circadian genes, rhythms and the biology of mood disorders. Pharmacol Ther. 2007 May;114(2):222-32. Epub 2007 Feb 28. Review. — View Citation

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. Epub 2006 Nov 20. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2003 Sep 19. — View Citation

Pjrek E, Winkler D, Kasper S. Pharmacotherapy of seasonal affective disorder. CNS Spectr. 2005 Aug;10(8):664-9; quiz 672. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ruhrmann S, Kasper S, Hawellek B, Martinez B, Höflich G, Nickelsen T, Möller HJ. Effects of fluoxetine versus bright light in the treatment of seasonal affective disorder. Psychol Med. 1998 Jul;28(4):923-33. — View Citation

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.

Thurber S, Snow M, Honts CR. The Zung Self-Rating Depression Scale: convergent validity and diagnostic discrimination. Assessment. 2002 Dec;9(4):401-5. — View Citation

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. — View Citation

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

ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. — View Citation

Zung WW. Factors influencing the self-rating depression scale. Arch Gen Psychiatry. 1967 May;16(5):543-7. — View Citation

* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) Monthly for duration of treatment (up to 4 months) No
Secondary Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) Monthly for duration of treatment (up to 4 months) No
Secondary 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) No
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