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

NCT ID: NCT00092911

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-05-31

Brief Summary

The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Conditions

Depression; Depressive Disorder; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DVS-233 SR

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatients
• Men and women age 18 years of age and older
• Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

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)
• Significant risk of suicide based on clinical judgment, including common

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

3151A1-320

Identifier Type: -

Identifier Source: org_study_id