Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00087737

Enrollment

369

Registered

2004-07-16

Start date

Unknown

Completion date

2005-05-31

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

Brief summary

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

Interventions

DRUGDVS-233 SR

DRUGVenlafaxine ER

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026