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

NCT ID: NCT00087737

Last Updated: 2009-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-05-31

Brief Summary

To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with MDD.

Conditions

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

Venlafaxine ER

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatients.
• Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
• Subjects must have a primary diagnosis of major depressive disorder

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

3151A1-317

Identifier Type: -

Identifier Source: org_study_id