Official Title: “An Open Label, Prospective and Multi-center Recurrence Prevention Study With Effexor XR in MDD Patients in China”

This primary purpose of this study is to assess the efficacy and safety of Effexor XR in preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD) following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month continuation treatment phases. The study will also collect data on the prevalence and pattern of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: October 2011

Intervention(s) in this Clinical Trial

• Drug: Effexor XR
• Other: Effexor XR discontinue

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Effexor XR
• Other: B
  • Effexor XR discontinue

Primary Measures

• time from entering maintenance phase to recurrence of major depression
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36)
  • Time Frame: 12 months
    Safety Issue?: Yes

• Inclusion criteria: 1. Males or females, 18 years of age or more; 2. Outpatients; 3.
• Major depressive disorder based on DSM-IV criteria, with/without current co-morbid anxiety disorder; 4. Has two or more episodes of depression (including the current episode) in the past 5 years, with an interval of at lease 2 months between the end of the previous episode and the beginning of the current episode. 5. The baseline score of 17-item
• Hamilton Rating Scale for Depression (HAM-D)>=17; 6 If female of childbearing potential, have a negative urine pregnancy test at baseline, if appropriate, and use a medically acceptable method of contraception throughout the study.
• Exclusion criteria:1.Hypersensitivity to venlafaxine;2.Received venlafaxine treatment before;3.Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure disorder (with the exception of a single childhood febrile seizure); 4.Alcohol or drug abuse within the last year;5.A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline);6.Bipolar disorder;7.For female, known or suspected pregnancy or breast feeding;8.Use of a monoamine oxidize inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.

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

Pfizer CT.gov Call Center Study Director Wyeth  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021  ClinicalTrials.gov_Inquiries@pfizer.com

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00878748

Study ID Number: 0600X1-4434

ClinicalTrials.gov Identifier: NCT00878748

Health Authority: China: State Food and Drug Administration