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NCT00683592 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
481
Enrollment target
9
Study locations

NCT00683592 is a Phase 3 study of Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 481 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (28% higher). The trial reports 9 study locations across 8 states.

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The verdict

NCT00683592, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
481 participants
Enrollment target
9
Study locations

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

145 total trials

What the Registry Record Tells You About NCT00683592

The ClinicalTrials.gov registry entry for NCT00683592 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (28% higher). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

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.

NCT00683592 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Washington, California, Florida.

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.

What interventions are being tested in trial NCT00683592?

The interventions under investigation include: placebo (DRUG), vilazodone (DRUG).

Who is sponsoring clinical trial NCT00683592?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.