NCT00087737

Brief Summary

To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with MDD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
369

participants targeted

Target at P25-P50 for phase_3 major-depressive-disorder

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

July 13, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
10 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

July 13, 2004

Last Update Submit

August 18, 2009

Conditions

Major Depressive Disorder

Interventions

DVS-233 SRDRUG
Venlafaxine ERDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients.
  • Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
  • Subjects must have a primary diagnosis of major depressive disorder

You may not qualify if:

  • Treatment with DVS-233 SR at any time in the past
  • Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood 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

July 13, 2004

First Posted

July 16, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

August 19, 2009

Record last verified: 2009-08