Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Desvenlafaxine Succinate; Paroxetine

Criteria

Primary Inclusion Criteria:

1. Outpatient men and women at least 18 years of age.

2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.

3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.

Primary Exclusion Criteria:

1. Treatment with DVS SR at any time in the past.

2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.

3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.