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

Last updated: March 2, 2012
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

4

Condition

Depression (Major/severe)

Affective Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT00474708
0600B2-4418
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 antidepressantmedication or have experienced intolerance due to side effects to their antidepressantmedication 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.

Exclusion

Main Exclusion Criteria:

  • Hypersensitivity to venlafaxine;

  • Clinically significant renal or hepatic disease or any other medical disease that, inthe 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 monthsof 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 anyinvestigational drug within 30 days of baseline.

  • Patients have prior use of venlafaxine or use of venlafaxine for the current episode.

Study Design

Total Participants: 1151
Study Start date:
April 01, 2007
Estimated Completion Date:
March 31, 2008

Connect with a study center

  • Beijing, Beijing 100096
    China

    Site Not Available

  • Guangzhou, Guangdong 510150
    China

    Site Not Available

  • Zhengzhou, Henan 450006
    China

    Site Not Available

  • Wuhan, Hubei 430022
    China

    Site Not Available

  • Changsha, Hunan 410011
    China

    Site Not Available

  • Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Shenyang, Liaoning 110168
    China

    Site Not Available

  • Jinan, Shandong 250014
    China

    Site Not Available

  • Shanghai, Shanghai 200080
    China

    Site Not Available

  • Xian, Shanxi 710061
    China

    Site Not Available

  • Tianjin, Tianjin 300350
    China

    Site Not Available

  • Hangzhou, Zhejiang 310013
    China

    Site Not Available

  • Huzhou, Zhejiang 313000
    China

    Site Not Available

  • Suzhou, Zhejiang 215008
    China

    Site Not Available

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