Study Evaluating DVS-233 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

NCT00063206

Enrollment

247

Registered

2003-06-25

Start date

Unknown

Completion date

2004-05-31

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

Keywords

Depressive Disorder, Major, Depression, Involutional

Brief summary

Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D\<sub\>17\</sub\>\] \< 7) versus those subjects receiving placebo.

Interventions

DRUGDVS-233 SR

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subjects must have a primary diagnosis of major depressive disorder (MDD) * Depressive symptoms for at least 30 days prior to the screening visit * Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D\<sub\>17\</sub\>)

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: Apr 6, 2026