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COMPLETED Phase 3

Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)

NCT00683592 · View on ClinicalTrials.gov ↗

Study Summary

This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG vilazodone

Study Locations (9)

Washington

  • Northwest Clinical Research Center — Bellevue
  • Summit Research Network — Seattle

California

  • Pharmacology Research Institute — Newport Beach

Florida

  • Florida Clinical Research Center — Bradenton

Georgia

  • Atlanta Institute of Medicine and Research — Atlanta

Oregon

  • Summit Research Network — Portland

Pennsylvania

  • University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders — Philadelphia

Texas

  • Mood Disorders Research Program and Clinic Exchange Park — Dallas

Utah

  • University of Utah Health Sciences Ctr, Dept of Psychiatry Mood Disorders Clinic — Salt Lake City

Trial Details

FieldValue
Enrollment Target 481 participants
Start Date 2008-03
Est. Completion 2009-03
Phase Phase 3

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00683592

The ClinicalTrials.gov registry entry for NCT00683592 describes a study currently listed as completed. It is categorized as Phase 3, 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 481 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 placebo 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: NCT00683592 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Washington, California, Florida. 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 NCT00683592 about?

NCT00683592 is a clinical study titled "Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)". This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.

What is the current status of trial NCT00683592?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2008-03. Estimated completion is 2009-03.

What conditions does trial NCT00683592 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 NCT00683592?

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

Who is sponsoring clinical trial NCT00683592?

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 NCT00683592 being conducted?

This trial has 9 study locations across California, Florida, Georgia, Oregon, Pennsylvania. 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