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Completed

NCT Number: NCT01608295

Vilazodone for Treatment of Geriatric Depression

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

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Key information

Conditions

Major Depressive Disorder Anxiety Disorders Behavior Behavioral Symptoms Consciousness Disorders Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vilazodone; Viibryd

Drug

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.

Other names: Vilazodone, Viibryd, Antidepressant

Paroxetine; Paxil

Drug

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.

Other names: Paroxetine, Paxil, Antidepressant

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

  1. UKU Side-effect Profile

    Time frame: Each visit for 12 weeks

    Number of participants with each side-effect event.

  2. Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test

    Time frame: Baseline and Final Visit

    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.

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

    Time frame: Baseline and Final Visit

    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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 31, 2012
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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