MedPath

Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Registration Number
NCT00075257
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Brief Summary

Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis.

Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] \< 7).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
603
Inclusion Criteria

Not provided

Exclusion Criteria
  • Treatment with DVS-233 SR at any time in the past
  • Treatment with venlafaxine (immediate release [IR] or ER) within 90 days of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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