Official Title: “The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China”

This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Effexor
  • Effexor XR Capsule, 75mg-225mg, s.i.d, 12weeks.
• Drug: SSRI
  • SSRI or Conventional Antidepressant Group

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1.Effexor XR Group
• Active Comparator: 2
  • 2.SSRI or Conventional Antidepressant Group

Primary Measures

• remission rate of Efexor XR® versus SSRIs& conventional antidepressants in depressed patients after previous antidepressant failure, as measured by HAM-D scores less than or equal to 7 after 12 weeks' treatment
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• efficacy and tolerability of Efexor XR® versus SSRIs& conventional antidepressants in subgroup of switched patients who have comorbid anxiety disorders/somatic symptoms.
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Main Inclusion Criteria:

• Males or females, 18 -65 years of age
• Outpatients
• Major depressive disorder based on DSM-IV criteria
• The baseline score of 17-item HAM-D³17
• Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
• Provide written informed consent
• If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.

Main Exclusion Criteria:

• Hypersensitivity to venlafaxine;
• Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
• Alcohol or drug abuse within the last year
• A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
• Bipolar disorder
• For female, known or suspected pregnancy or breast feeding
• Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
• Patients have prior use of venlafaxine or use of venlafaxine for the current episode.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00474708

Study ID Number: 0600B2-4418

ClinicalTrials.gov Identifier: NCT00474708

Health Authority: China: State Food and Drug Administration