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NCT01473394 · ClinicalTrials.gov registry record · Phase 4
Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder
A Phase 4 study of Major Depressive Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 518
- Enrollment target
- 14
- Study locations
NCT01473394: Completed Phase 4 study of Major Depressive Disorder, sponsored by Forest Laboratories.
NCT01473394 is a Phase 4 study of Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 518 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (38% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473394, a Phase 4 study of Major Depressive Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 518 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.
Primary Outcome
The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and
Conditions Studied
Interventions
- DRUG Vilazodone
- DRUG Dose-matched placebo
Study Locations (14)
California
- Forest Investigative Site 009 - Beverly Hills
- Forest Investigative Site 003 - Encino
- Forest Investigative Site 010 - New Port Beach
Florida
- Forest Investigative Site 005 - Jacksonville
- Forest Investigative Site 004 - Orlando
Washington
- Forest Investigative Site 006 - Bellevue
- Forest Investigative Site 013 - Seattle
Georgia
- Forest Investigative Site 012 - Atlanta
Maryland
- Forest Investigative Site 001 - Baltimore
Ohio
- Forest Investigative Site 002 - Dayton
Pennsylvania
- Forest Investigative Site 011 - Philadelphia
Rhode Island
- Forest Investigative Site 015 - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01473394 record still lists
NCT01473394 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Vilazodone is the first listed.
NCT01473394 lists 14 locations in 10 states (California, Florida, Washington).
Frequently Asked Questions
What is clinical trial NCT01473394 about?
NCT01473394 is a clinical study titled "Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder". The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.
What is the current status of trial NCT01473394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 518 participants. The study started on 2011-12. Estimated completion is 2013-02.
What conditions does trial NCT01473394 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01473394?
The interventions under investigation include: Vilazodone (DRUG), Dose-matched placebo (DRUG).
Who is sponsoring clinical trial NCT01473394?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01473394 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01473394's enrollment target sits among peer trials
518 30th of 282 higher than 253 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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