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

NCT00683592 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2010-10-27

Study results available
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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

Interventions

DRUG

vilazodone

titration to 40 mg tablets qd (once a day) for 8 weeks

DRUG

placebo

placebo

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Carol R Reed, MD · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683592 on ClinicalTrials.gov