Vilazodone for Treatment of Geriatric Depression

University of California, Los Angeles65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Vilazodone; ViibrydDRUG

Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.

Paroxetine; PaxilDRUG

Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

UCLA Semel Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS)

The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.

Time frame: Baseline and 12 weeks

Secondary Outcomes

UKU Side-effect Profile

Number of participants with each side-effect event.

Time frame: Each visit for 12 weeks

Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test

The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.

Time frame: Baseline and Final Visit

Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)

Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.

Time frame: Baseline and Final Visit

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.