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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: SSRI; Drug: Effexor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474708

0600B2-4418

Details and patient eligibility

About

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.

Enrollment: 1,151 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,151 participants in 2 patient groups

1

Experimental group

Description:

1.Effexor XR Group

Treatment:

Drug: Effexor

2

Active Comparator group

Description:

2.SSRI or Conventional Antidepressant Group

Treatment:

Drug: SSRI