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NCT01473381 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Vilazodone in Major Depressive Disorder
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,162
- Enrollment target
NCT01473381: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT01473381 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 1,162 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473381, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,162 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.
Primary Outcome
The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum se
Interventions
- DRUG Citalopram
- DRUG Vilazodone
- DRUG Placebo to citalopram
- DRUG Placebo to vilazodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,162 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01473381 record still lists
NCT01473381 is an interventional study that assigns participants to a tested intervention. Its 1,162 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (124% higher).
The record links to 0 conditions, and to 4 interventions - of which Citalopram is the first listed.
NCT01473381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01473381 about?
NCT01473381 is a clinical study titled "Safety and Efficacy of Vilazodone in Major Depressive Disorder". The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.
What is the current status of trial NCT01473381?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,162 participants. The study started on 2011-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01473381?
The interventions under investigation include: Citalopram (DRUG), Vilazodone (DRUG), Placebo to citalopram (DRUG), Placebo to vilazodone (DRUG).
Who is sponsoring clinical trial NCT01473381?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01473381's enrollment target sits among peer trials
1,162 63rd of 2000 higher than 1,938 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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