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COMPLETED Phase 4

Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

NCT01473394 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 518 participants
Start Date 2011-12
Est. Completion 2013-02
Phase Phase 4

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01473394

The ClinicalTrials.gov registry entry for NCT01473394 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 518 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01473394 reports 14 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01473394?

The interventions under investigation include: Vilazodone (DRUG), Dose-matched placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01473394?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial