Phase 4 N=56 Randomized Double-blind Treatment

Vilazodone for Treatment of Geriatric Depression

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01608295 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Hamilton Depression Rating Scale (HDRS) — 17.2; 16.6; 7.6; 7.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vilazodone; Viibryd (Drug); Paroxetine; Paxil (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale (HDRS)	17.2; 16.6; 7.6; 7.5	—
SECONDARY UKU Side-effect Profile	3; 0; 1; 3; 3; 3	—
SECONDARY Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test	13.3; 13.3; 15.2; 16.3	—
SECONDARY Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)	-0.8; -1.25; 0.2; -2.1	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01608295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.