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 Two Fixed Doses (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

NCT00073762

Enrollment

375

Registered

2003-12-08

Start date

Unknown

Completion date

2004-09-30

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

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.

Interventions

DRUGDVS-233 SR

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 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)

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