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

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
2	SSRI	2.SSRI or Conventional Antidepressant Group
1	Effexor	1.Effexor XR Group

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving Remission	12 weeks	Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)	12 weeks	Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.