NCT00073762

Brief Summary

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] less than or equal to 7) versus those subjects receiving placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
375

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

December 4, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

December 4, 2003

Last Update Submit

August 18, 2009

Conditions

Major Depressive Disorder

Interventions

DVS-233 SRDRUG

Eligibility Criteria

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

You may qualify if:

  • Outpatients
  • Sexually active women participating in the study must use a medically acceptable form of contraception
  • Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

    PMID: 25758058DERIVED

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

December 4, 2003

First Posted

December 8, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

August 19, 2009

Record last verified: 2009-08