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Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Effexor XR (Drug); Effexor XR discontinue (Other)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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

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

Primary outcome: time from entering maintenance phase to recurrence of major depression

Secondary outcome: Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: September 21, 2010

Page last updated: August 23, 2015

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