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Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Three Fixed Doses (100 Mg, 200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00072774
Enrollment
480
Registered
2003-11-13
Start date
Unknown
Completion date
2004-11-30
Last updated
2009-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Depressive Disorder, Major, Melancholia, Involutional, Depression, Involutional

Brief summary

To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Interventions

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026