Official Title: “A Multicenter, Randomized, Double-Blind, Paroxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Sustained-Release Tables in Adult Outpatients With Major Depressive Disorder”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg.

Additional objectives include obtaining general and functional quality of life outcome data.

Intervention(s) in this Clinical Trial

• Drug: DVS-233 SR
  • Arm 1: 50mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS tablet, QD, 8 weeks treatment with 2 week taper
• Drug: Paroxetine
  • 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Experimental: C
• Active Comparator: D

Primary Measures

• The primary efficacy outome measure will be the mean total score of the 17-item Hamilton Depression Scale (HAM-D17).
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Clinical Global Impressions Scale Severity of Illness (CGI-S), the Clinical Global Impressions Scale Improvement (CGI-I), the Montgomery and Asberg Depression Rating Scale total score
  • Time Frame: 8 weeks
    Safety Issue?: No
• The Hamilton Depression rating scale - 6 item (HAM-D6), Covi-Anxiety Scale, and the visual analog scale-pain intensity
  • Time Frame: 8 weeks
    Safety Issue?: No

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.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00445679

Study ID Number: 3151A1-336

ClinicalTrials.gov Identifier: NCT00445679

Health Authority: China: Ministry of Health