Vilazodone for Treatment of Geriatric Depression

This is a 12-week double-blind comparison of a novel antidepressant, vilazodone, to the
gold-standard drug, paroxetine, for the treatment of geriatric depression. We are interested
in assessing the difference in response to vilazodone (VLZ) compared to paroxetine (PAR). We
hope to detect difference in response in primary outcomes (depressed mood) and secondary
outcomes cognition. We are seeking to examine this directly in 80 older adults (60 years of
age or older) with major depression with anticipated 60 completers. This proposed trial will
serve as a pilot study to estimate the efficacy and tolerability of the drug in older
depressed adults, and use this project for dose-finding in this population.

Inclusion Criteria:

- 60 years of age or older

- The presence of a major depressive disorder diagnosed according to the Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV) criteria

- A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline

- Mini-Mental State Exam (MMSE) score > 24.

Exclusion Criteria:

- Subjects will be excluded if they had any current and/or lifetime history of other
psychiatric disorders (except unipolar depression with or without comorbid generalized
anxiety disorder), or recent unstable medical or neurological disorders; any
disabilities preventing their participation in the study; diagnosis of mild cognitive
impairment (MCI)/dementia; those with known allergic reactions to paroxetine or
vilazodone.