Study of Antidepressants in Parkinson's Disease (SAD-PD)
3. ledna 2013 aktualizováno: Irene Richard, University of Rochester
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.
The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
Typ studie
Intervenční
Zápis (Aktuální)
115
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ontario
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London, Ontario, Kanada, N6A 5A5
- London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
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Quebec
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Montreal, Quebec, Kanada, H2W 1T8
- Hotel-Dieu Hospital-CHUM
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San Juan, Portoriko, 00936
- University of Puerto Rico
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California
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San Francisco, California, Spojené státy, 94143
- University of California San Francisco
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Florida
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Gainesville, Florida, Spojené státy, 32610
- University of Florida
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Miami, Florida, Spojené státy, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University School of Medicine
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Kentucky
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Lexington, Kentucky, Spojené státy, 40536
- University of Kentucky
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Maryland
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Baltimore, Maryland, Spojené státy, 21218
- Johns Hopkins University
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Baltimore, Maryland, Spojené státy, 21250
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
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Missouri
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St. Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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New York
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Rochester, New York, Spojené státy, 14627
- University of Rochester
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Ohio
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Toledo, Ohio, Spojené státy
- Medical University of Ohio
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Oregon Health Sciences University
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Tennessee
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Memphis, Tennessee, Spojené státy, 38163
- University of Tennessee-Memphis
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Texas
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Houston, Texas, Spojené státy, 77030
- Baylor College of Medicine, 6550 Fannin, Suite 1801
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Virginia
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Charlottesville, Virginia, Spojené státy, 22901
- University of Virginia
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
30 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
To be eligible you must be:
- 30 years old or older
- diagnosed with Parkinson's disease
- experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks.
If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated).
Dosage for this study will not exceed 40 mg.
Ostatní jména:
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Aktivní komparátor: venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks.
If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated).
Dosage for this study will not exceed 225 mg.
Ostatní jména:
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Komparátor placeba: placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
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neaktivní látka
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Hamilton Depression Rating Scale (HAM-D) Scores
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Hamilton Rating Scale for Depression over 12 weeks.
Hamilton Depression Rating Scale ranges from 0-50.
Higher scores represent more significant depression.
Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Montgomery-Asberg Depression Rating Scale ranges from 0-60.
Higher score indicates more severe depression.
0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Beck Depression Inventory II (BDI-II)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Beck Depression Inventory II ranges from 0-63.
Higher score indicates more severe depression.
0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Geriatric Depression Rating Scale (GDS)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Geriatric Depression Scale ranges from 0-30.
Higher score indicates more severe depression.
0-9 normal, 10-19 mild depression, 20-30 severe depression.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Brief Psychiatric Rating Scale (BPRS)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Brief Psychiatric Rating Scale.
Maximum score 126.
Higher score indicates greater psychiatric difficulties.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Unified Parkinson's Disease Rating Scale.
Higher score indicates more severe Parkinson's disease symptoms.
Total maximum = 176.
Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72.
Minimum = 0.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Snaith Clinical Anxiety Scale (CAS)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Snaith Clinical Anxiety Scale.
Range 0-21.
Higher scores indicate increased anxiety.
Score greater than 8 indicates clinical anxiety.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Pittsburgh Sleep Quality Index (PSQI)
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23.
Higher score indicates more severe Parkinson's disease symptoms.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Parkinson's Disease Questionnaire (PDQ-39) Total.
Range 0-100.
Lower score indicates a better perceived health status.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Short Form 36 Health Survey - Mental Component Summary
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Short Form 36 Health Survey.
Range 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Short Form 36 Health Survey - Vitality
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Short Form 36 Health Survey - Vitality subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Short Form 36 Health Survey - Role-Emotional
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Short Form 36 Health Survey - Emotional subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Change in Short Form 36 Health Survey - Mental Health
Časové okno: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Short Form 36 Health Survey - Mental Health subscale ranges from 0-100.
Higher score indicates a better perceived quality of life.
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from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Irene Richard, MD, University of Rochester
- Vrchní vyšetřovatel: William McDonald, MD, Co-Principal Investigator--Emory University School of Medicine
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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-#.
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- 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.
- 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.
- 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.
- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2005
Primární dokončení (Aktuální)
1. listopadu 2009
Dokončení studie (Aktuální)
1. listopadu 2009
Termíny zápisu do studia
První předloženo
28. června 2004
První předloženo, které splnilo kritéria kontroly kvality
28. června 2004
První zveřejněno (Odhad)
29. června 2004
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
4. ledna 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. ledna 2013
Naposledy ověřeno
1. ledna 2013
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Symptomy chování
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Parkinsonské poruchy
- Bazální gangliové choroby
- Poruchy pohybu
- Synukleinopatie
- Neurodegenerativní onemocnění
- Deprese
- Parkinsonova choroba
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Psychotropní drogy
- Inhibitory vychytávání serotoninu
- Inhibitory vychytávání neurotransmiterů
- Membránové transportní modulátory
- Serotoninové látky
- Antidepresiva
- Inhibitory enzymu cytochromu P-450
- Antidepresiva, druhá generace
- Inhibitory zpětného vychytávání serotoninu a noradrenalinu
- Cytochrom P-450 Inhibitory CYP2D6
- Paroxetin
- Venlafaxin hydrochlorid
Další identifikační čísla studie
- R01NS046487 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .