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Clinical Trials/NCT00073762
NCT00073762CompletedPhase 3

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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites375 target enrollmentStarted: December 8, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
375
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor Class
Industry

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Study Evaluating DVS-233 SR In Adult... | Clinical Trial