CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
Vilazodone +1 moredrug
Likely dose
Vilazodone 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01742832
NCT01742832Phase 2Completed

Double-Blind Switch Study of Vilazodone in the Treatment of Major Depressive Disorder Following Partial Response to or Inability to Tolerate a Generic SSRI

University of Chicago·interventional·Posted Dec 5, 2012·Updated Feb 23, 2023

In Brief

A Phase 2 clinical trial evaluating Vilazodone and Citalopram for Major Depressive Disorder. Completed, enrolled 79 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of vilazodone for the treatment of major depressive disorder versus citalopram. Doctors want to determine if vilazodone is effective for the treatment of major depressive disorder in those who have not responded to generic selective serotonin reuptake inhibitors (SSRI), which is a class of anti-depressant drugs such as Prozac, Lexapro, Paxil, or Zoloft. Both vilazodone and citalopram have been approved for the treatment of major depressive disorder. This research is being done because the researchers want to find out if vilazodone works in reducing the symptoms of depression significantly more than a generic SSRI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2012
Enrollment StartMay 1, 2013
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.6 years ago

Interventions

Vilazodonedrug

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Citalopramdrug

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.