Status:

WITHDRAWN

Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 mai...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2011

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00878748

    Start Date

    April 1 2009

    End Date

    October 1 2011

    Last Update

    August 20 2021

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