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

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.

Completed

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DVS-233 SR

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Primary completion: 2004
Study completion: 2004
First posted: Jun 25, 2003
Registry last updated: Aug 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed