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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092911

Enrollment

244

Registered

2004-09-28

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

Depression, Depressive Disorder, Major Depressive Disorder

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.

Interventions

DRUGDVS-233 SR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

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) * Significant risk of suicide based on clinical judgment, including common

Outcome results

None listed

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