The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.
Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden. Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial. A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Paroxetine CR 12.5 - 25 mg q hs
nortriptyline 25 - 75 mg q hs
matching placebo
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Hamilton Depression Scale
total score on HDRS (0-54 higher score is worse)
Time frame: 8 weeks
Percent Responders
Percent of patients who had a 50% decrease in total HDRS at 8 weeks
Time frame: 8 weeks
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