Study of Antidepressants in Parkinson's Disease

Summary

The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.

Timeline

Start

2005-06

Primary completion

2009-11

Completion

2009-11

Publications

• Background Dooneief G, Mirabello E, Bell K, Marder K, Stern Y, Mayeux R. An estimate of the incidence of depression in idiopathic Parkinson's disease. Arch Neurol. 1992 Mar;49(3):305-7. doi: 10.1001/archneur.1992.00530270125028.
• Background Liu CY, Wang SJ, Fuh JL, Lin CH, Yang YY, Liu HC. The correlation of depression with functional activity in Parkinson's disease. J Neurol. 1997 Aug;244(8):493-8. doi: 10.1007/s004150050131.
• Background Kuopio AM, Marttila RJ, Helenius H, Toivonen M, Rinne UK. The quality of life in Parkinson's disease. Mov Disord. 2000 Mar;15(2):216-23. doi: 10.1002/1531-8257(200003)15:23.0.co;2-#.
• Background Phillips P. Keeping depression at bay helps patients with Parkinson disease. JAMA. 1999 Sep 22-29;282(12):1118-9. No abstract available.
• Background Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010.
• Background Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17.
• Background Devos D, Dujardin K, Poirot I, Moreau C, Cottencin O, Thomas P, Destee A, Bordet R, Defebvre L. Comparison of desipramine and citalopram treatments for depression in Parkinson's disease: a double-blind, randomized, placebo-controlled study. Mov Disord. 2008 Apr 30;23(6):850-7. doi: 10.1002/mds.21966.
• Background Yeragani VK, Roose S, Mallavarapu M, Radhakrishna RK, Pesce V. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on measures of nonlinearity and chaos of heart rate. Neuropsychobiology. 2002;46(3):125-35. doi: 10.1159/000066390.
• Background Yeragani VK, Pesce V, Jayaraman A, Roose S. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on long-term heart rate variability measures. Biol Psychiatry. 2002 Sep 1;52(5):418-29. doi: 10.1016/s0006-3223(02)01394-x.
• Background Nelson JC, Kennedy JS, Pollock BG, Laghrissi-Thode F, Narayan M, Nobler MS, Robin DW, Gergel I, McCafferty J, Roose S. Treatment of major depression with nortriptyline and paroxetine in patients with ischemic heart disease. Am J Psychiatry. 1999 Jul;156(7):1024-8. doi: 10.1176/ajp.156.7.1024.
• Background Simons JA. Fluoxetine in Parkinson's disease. Mov Disord. 1996 Sep;11(5):581-2. doi: 10.1002/mds.870110517. No abstract available.
• Background Steur EN. Increase of Parkinson disability after fluoxetine medication. Neurology. 1993 Jan;43(1):211-3. doi: 10.1212/wnl.43.1_part_1.211.
• Background Jimenez-Jimenez FJ, Tejeiro J, Martinez-Junquera G, Cabrera-Valdivia F, Alarcon J, Garcia-Albea E. Parkinsonism exacerbated by paroxetine. Neurology. 1994 Dec;44(12):2406. doi: 10.1212/wnl.44.12.2406. No abstract available.
• Background Salzman C. Pharmacologic treatment of depression in the elderly. J Clin Psychiatry. 1993 Feb;54 Suppl:23-8.
• Background Altamura AC, De Novellis F, Guercetti G, Invernizzi G, Percudani M, Montgomery SA. Fluoxetine compared with amitriptyline in elderly depression: a controlled clinical trial. Int J Clin Pharmacol Res. 1989;9(6):391-6.
• Background Feighner JP, Boyer WF, Meredith CH, Hendrickson G. An overview of fluoxetine in geriatric depression. Br J Psychiatry Suppl. 1988 Sep;(3):105-8. No abstract available.
• Background Cohn CK, Shrivastava R, Mendels J, Cohn JB, Fabre LF, Claghorn JL, Dessain EC, Itil TM, Lautin A. Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients. J Clin Psychiatry. 1990 Dec;51 Suppl B:28-33.
• Background Dubovsky S. Geriatric Neuropsychopharmacology. In: Coffey C, Cummings J, eds. Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, 1994:595-631.
• Background Dunner DL, Cohn JB, Walshe T 3rd, Cohn CK, Feighner JP, Fieve RR, Halikas JP, Hartford JT, Hearst ED, Settle EC Jr, et al. Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression. J Clin Psychiatry. 1992 Feb;53 Suppl:57-60.
• Background Guillibert E, Pelicier Y, Archambault JC, Chabannes JP, Clerc G, Desvilles M, Guibert M, Pagot R, Poisat JL, Thobie Y. A double-blind, multicentre study of paroxetine versus clomipramine in depressed elderly patients. Acta Psychiatr Scand Suppl. 1989;350:132-4. doi: 10.1111/j.1600-0447.1989.tb07192.x. No abstract available.
• Background Hirschfeld RM. Efficacy of SSRIs and newer antidepressants in severe depression: comparison with TCAs. J Clin Psychiatry. 1999 May;60(5):326-35. doi: 10.4088/jcp.v60n0511.
• Background Entsuah AR, Huang H, Thase ME. Response and remission rates in different subpopulations with major depressive disorder administered venlafaxine, selective serotonin reuptake inhibitors, or placebo. J Clin Psychiatry. 2001 Nov;62(11):869-77. doi: 10.4088/jcp.v62n1106.
• Background Gentil V, Kerr-Correa F, Moreno R, D'Arrigo Busnello E, De Campos JA, Juruena MF, Lafer B, Moreno DH, De Cassia Rodrigues RL, Tiosso A, Benedictis E. Double-blind comparison of venlafaxine and amitriptyline in outpatients with major depression with or without melancholia. J Psychopharmacol. 2000 Mar;14(1):61-6. doi: 10.1177/026988110001400108.
• Background Applebaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press, 2001.
• Background American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994.
• Background Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for Axis I DSM-IV disorders: Biometrics Research Department. New York State Psychiatric Institute 1994.
• Background Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
• Background HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
• Background Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
• Background Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
• Background Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
• Background Conners CK, Barkley RA. Rating scales and checklists for child psychopharmacology. Psychopharmacol Bull. 1985;21(4):809-43. No abstract available.
• Background Fahn S, Elton RL. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson's Disease. Florham Park, NJ: MacMillan Healthcare Information, 1992:153-163.
• Background Uc EY, McDermott MP, Marder KS, Anderson SW, Litvan I, Como PG, Auinger P, Chou KL, Growdon JC; Parkinson Study Group DATATOP Investigators. Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort. Neurology. 2009 Nov 3;73(18):1469-77. doi: 10.1212/WNL.0b013e3181bf992f.
• Background Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.
• Background Little RJA, Rubin DB. Statistical Analysis with Missing Data, Second Edition. Hoboken: John Wiley and Sons, 2002.
• Background McDonald WM, Holtzheimer PE, Haber M, Vitek JL, McWhorter K, Delong M. Validity of the 30-item geriatric depression scale in patients with Parkinson's disease. Mov Disord. 2006 Oct;21(10):1618-22. doi: 10.1002/mds.21023.
• Background Okun MS, Fernandez HH. Will tricyclic antidepressants make a comeback for depressed Parkinson disease patients? Neurology. 2009 Mar 10;72(10):868-9. doi: 10.1212/01.wnl.0000338145.24512.02. Epub 2008 Dec 17. No abstract available.
• Background Brunoni AR, Lopes M, Kaptchuk TJ, Fregni F. Placebo response of non-pharmacological and pharmacological trials in major depression: a systematic review and meta-analysis. PLoS One. 2009;4(3):e4824. doi: 10.1371/journal.pone.0004824. Epub 2009 Mar 18.
• Background Senn S, Julious S. Measurement in clinical trials: a neglected issue for statisticians? Stat Med. 2009 Nov 20;28(26):3189-209. doi: 10.1002/sim.3603.

Drugs

Indications