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Phase 4 Completed N=1,158 Randomized Treatment

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

Source: ClinicalTrials.gov NCT00474708 ↗
Enrolled (actual)
1,158
Serious AEs
Results posted
Apr 2010
Primary outcomePrimary: Number of Patients Achieving Remission — 554; 207 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients Achieving Remission
554; 207
SECONDARY
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
60; 23; 494; 184

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00474708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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