Vilazodone for Treatment of Geriatric Depression

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Paroxetine; Paxil; Drug: Vilazodone; Viibryd

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01608295

VII-IT-02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 65 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

65 participants in 2 patient groups

Vilazodone; Viibryd

Experimental group

Description:

After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.

Treatment:

Drug: Vilazodone; Viibryd

Paroxetine; Paxil

Experimental group

Description:

After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.

Treatment:

Drug: Paroxetine; Paxil