Vilazodone for Treatment of Geriatric Depression

A Pilot Study of Double-blind Comparison of Vilazodone to Paroxetine in Geriatric Depression

The purpose of this study is to examine the effects of vilazodone for the treatment of depression in older adults.

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.