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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites247 target enrollmentJune 25, 2003

ConditionsMajor Depressive Disorder

DrugsDVS-233 SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 247
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2003

End Date

May 2004

Last Updated

16 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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)