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A controlled trial of antidepressants in patients with Parkinson disease and depression

From the Departments of Psychiatry (M.M., R.D.D., H.M., M.H.M., M.G., K.B., A.D.) and Neurology (M.M., M.H.M.) at the Robert Wood Johnson Medical School, UMDNJ-University Behavioral HealthCare (M.M., H.M., M.G.), and the Department of Statistics at Rutgers University (S.B.), Piscataway, NJ.

Address correspondence and reprint requests to Dr. Matthew Menza, Robert Wood Johnson Medical School, D207A, 671 Hoes Lane, Piscataway, NJ 08854 menza{at}umdnj.edu

Background: Parkinson disease (PD) is a common neurodegenerative disease affecting up to 1 million individuals in the United States. Depression affects up to 50% of these patients and is associated with a variety of poor outcomes for patients and their families. Despite this, there are few evidence-based data to guide clinical care.

Methods: An NIH-funded, randomized, controlled trial of paroxetine CR, nortriptyline, and placebo in 52 patients with PD and depression. The primary outcomes were the change in the Hamilton Depression Rating Scale (HAM-D) and the percentage of depression responders at 8 weeks.

Results: Nortriptyline was superior to placebo for the change in HAM-D (p < 0.002); paroxetine CR was not. There was a trend for superiority of nortriptyline over paroxetine CR at 8 weeks (p < 0.079). Response rates favored nortriptyline (p = 0.024): nortriptyline 53%, paroxetine CR 11%, placebo 24%. In planned contrasts of response rates, nortriptyline was superior to paroxetine CR (p = 0.034). Nortriptyline was also superior to placebo in many of the secondary outcomes, including sleep, anxiety, and social functioning, while paroxetine CR was not. Both active drug treatments were well tolerated.

Conclusions: Though relatively modest in size, this is the largest placebo-controlled trial done to date in patients with Parkinson disease (PD) and depression. Nortriptyline was efficacious in the treatment of depression and paroxetine CR was not. When compared directly, nortriptyline produced significantly more responders than did paroxetine CR. The trial suggests that depression in patients with PD is responsive to treatment and raises questions about the relative efficacy of dual reuptake inhibitors and selective serotonin reuptake inhibitors.

ARR = absolute risk reduction; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition; HAM-A = Hamilton Anxiety Scale; HAM-D = Hamilton Depression Rating Scale; MMSE = Mini-Mental State Examination; NNT = number needed to treat; PD = Parkinson disease; PDQ = Parkinson’s Disease Questionnaire; PSQI = Pittsburgh Sleep Quality Index; SCID = Structured Clinical Interview; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; UPDRS = Unified Parkinson’s Disease Rating Scale.

Editorial, page 868

e-Pub ahead of print on December 17, 2008, at www.neurology.org.

Supported by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) RO1NS043144. GlaxoSmithKline provided free paroxetine CR and matching placebo.

Disclosure: Matthew Menza, MD—research support: National Institutes of Health (NINDS), Astra-Zeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Forest Laboratories, GlaxoSmithKline, Lilly, Pfizer, Sanofi-Aventis, Sepracor, Takeda Wyeth. Consultant: National Institutes of Health (NIMH, NINDS), GlaxoSmithKline, Kyowa, Lilly Research Laboratories, Pfizer, Sepracor, Takeda. Speaker: Sanofi-Aventis. Stocks: none. Other financial: none; Roseanne DeFronzo Dobkin, PhD—research support: National Institutes of Health (NINDS); Humberto Marin, MD—research support: National Institutes of Health (NINDS), GlaxoSmithKline, Lilly, Sanofi-Aventis, Sepracor, Takeda. Consultant: Lilly Research Laboratories; Margery Mark, MD: research support: Kyowa, Cephalon. Speaker: Allergan, Boehringer Ingelheim, GlaxoSmithKline, Valeant; Michael Gara, PhD—none; Steven Buyske, PhD—research support: National Institutes of Health (NIAAA); Karina Bienfait, PhD—none; Allison Dicke—none.

Received March 31, 2008. Accepted in final form August 22, 2008.

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