NCT00092911

Brief Summary

The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P50-P75 for phase_3 depression

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

September 24, 2004

Last Update Submit

August 18, 2009

Conditions

DepressionDepressive DisorderMajor Depressive Disorder

Interventions

DVS-233 SRDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients
  • Men and women age 18 years of age and older
  • Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

You may not qualify if:

  • Treatment with DVS-233 SR at any time in the past
  • Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER)
  • Significant risk of suicide based on clinical judgment, including common

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionDepressive DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2004

First Posted

September 28, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

August 19, 2009

Record last verified: 2009-08