Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

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.

Intervention(s) in this Clinical Trial

• Drug: Effexor
• Drug: SSRI

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

• Number of Patients Achieving Remission
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
  • 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 Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Information obtained from ClinicalTrials.gov on February 02, 2012

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