Depression is common in patients with Parkinson's Disease (PD), and is a major factor negatively impacting quality-of-life. To date, there have been no well-designed clinical trials of anti-depressant pharmacotherapy for depression in PD. Selective Serotonin Reuptake Inhibitor (SSRI) and, more recently, combined Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) anti-depressants are used as a first-line treatment for depression. However, their efficacy and tolerability in PD have not been established, and there are several important reasons why results from studies in primary psychiatric populations cannot simply be extrapolated to patients with PD. In PD, the underlying pathophysiology and somewhat atypical depressive features may result in a different anti-depressant response. Furthermore, PD patients are particularly vulnerable to antidepressant-induced extrapyramidal side effects, and a host of factors (including concomitant anti-Parkinsonian medications) may affect the general tolerability of these agents. The proposed clinical trial has been designed to compare the efficacy and tolerability of Paroxetine (an SSRI) and Venlafaxine (an SNRI) in PD patients with depression. Information regarding the effects of these medications on motor function, quality-of-life, and cognition will also be obtained. Two-hundred, twenty-eight subjects will be enrolled among 15 centers, and each subject will participate in the trial for 12 weeks. The trial will clarify many important questions regarding the treatment of depression in patients with PD. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
1R01NS046487-01A1
Application #
6784427
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Conwit, Robin
Project Start
2004-07-01
Project End
2008-04-30
Budget Start
2004-07-01
Budget End
2005-04-30
Support Year
1
Fiscal Year
2004
Total Cost
$1,125,694
Indirect Cost
Name
University of Rochester
Department
Neurology
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
Broen, M P G; Leentjens, A F G; Köhler, S et al. (2016) Trajectories of recovery in depressed Parkinson's disease patients treated with paroxetine or venlafaxine. Parkinsonism Relat Disord 23:80-5
Moonen, A J H; Wijers, A; Leentjens, A F G et al. (2014) Severity of depression and anxiety are predictors of response to antidepressant treatment in Parkinson's disease. Parkinsonism Relat Disord 20:644-6
Richard, I H; McDermott, M P; Kurlan, R et al. (2012) A randomized, double-blind, placebo-controlled trial of antidepressants in Parkinson disease. Neurology 78:1229-36
Hegde, Manu; Glass, Graham A; Dalmau, Josep et al. (2011) A case of slow orthostatic tremor, responsive to intravenous immunoglobulin. Mov Disord 26:1563-5
Logigian, E L; Martens, W B; Moxley 4th, R T et al. (2010) Mexiletine is an effective antimyotonia treatment in myotonic dystrophy type 1. Neurology 74:1441-8
Montes, J; McDermott, M P; Martens, W B et al. (2010) Six-Minute Walk Test demonstrates motor fatigue in spinal muscular atrophy. Neurology 74:833-8
Uc, E Y; McDermott, M P; Marder, K S et al. (2009) Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort. Neurology 73:1469-77
Christine, C W; Starr, P A; Larson, P S et al. (2009) Safety and tolerability of putaminal AADC gene therapy for Parkinson disease. Neurology 73:1662-9