A randomized, double-blind, placebo-controlled trial of antidepressants in Parkinson disease
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Abstract
Objective: To evaluate the efficacy and safety of a selective serotonin reuptake inhibitor (SSRI) and a serotonin and norepinephrine reuptake inhibitor (SNRI) in the treatment of depression in Parkinson disease (PD).
Methods: A total of 115 subjects with PD were enrolled at 20 sites. Subjects were randomized to receive an SSRI (paroxetine; n = 42), an SNRI (venlafaxine extended release [XR]; n = 34), or placebo (n = 39). Subjects met DSM-IV criteria for a depressive disorder, or operationally defined subsyndromal depression, and scored >12 on the first 17 items of the Hamilton Rating Scale for Depression (HAM-D). Subjects were followed for 12 weeks (6-week dosage adjustment, 6-week maintenance). Maximum daily dosages were 40 mg for paroxetine and 225 mg for venlafaxine XR. The primary outcome measure was change in the HAM-D score from baseline to week 12.
Results: Treatment effects (relative to placebo), expressed as mean 12-week reductions in HAM-D score, were 6.2 points (97.5% confidence interval [CI] 2.2 to 10.3, p = 0.0007) in the paroxetine group and 4.2 points (97.5% CI 0.1 to 8.4, p = 0.02) in the venlafaxine XR group. No treatment effects were seen on motor function.
Conclusions: Both paroxetine and venlafaxine XR significantly improved depression in subjects with PD. Both medications were generally safe and well tolerated and did not worsen motor function.
Classification of Evidence: This study provides Class I evidence that paroxetine and venlafaxine XR are effective in treating depression in patients with PD.
GLOSSARY
- BDI-II=
- Beck Depression Inventory II;
- CGI=
- Clinical Global Impression Scale;
- CI=
- confidence interval;
- CTCC=
- Clinical Trials Coordination Center;
- dPD=
- depression in Parkinson disease;
- DSM-IV=
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition;
- GDS=
- Geriatric Depression Scale;
- HAM-D=
- Hamilton Rating Scale for Depression;
- MADRS=
- Montgomery-Åsberg Depression Rating Scale;
- PD=
- Parkinson disease;
- SAD-PD=
- Study of Antidepressants in Parkinson Disease;
- SF=
- Short Form;
- SNRI=
- serotonin and norepinephrine reuptake inhibitor;
- SSRI=
- selective serotonin reuptake inhibitor;
- TCA=
- tricyclic antidepressant;
- UPDRS=
- Unified Parkinson's Disease Rating Scale;
- XR=
- extended release.
Footnotes
Study funding: Supported by NIH/NINDS R01 NS046487 and the General Clinical Research Center at Johns Hopkins University School of Medicine (National Center for Research Resources/NIH M01-RR00052). Wyeth Pharmaceuticals provided venlafaxine XR and matching placebo. Glaxo-Smith Kline provided paroxetine.
Editorial, page 1198
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Supplemental data at www.neurology.org
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Coinvestigators are listed on the Neurology® Web site at www.neurology.org.
- Received June 8, 2011.
- Accepted October 18, 2011.
- Copyright © 2012 by AAN Enterprises, Inc.
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