MedTrace Logo

A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

NCT00644358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2017-09-25

Study results available
· View outcomes & findings →

Summary

This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.

Conditions

Interventions

DRUG

vilazodone

titration to 40 milligrams (mg) every day (qd) for 1 year

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Carol R Reed, MD · Forest Laboratories

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00644358 on ClinicalTrials.gov