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

The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Effexor; Drug: SSRI

• Study Type: Interventional
• Enrollment (Actual): 1151
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100080
    • Beijing, Beijing, China, 100083
    • Beijing, Beijing, China, 100096
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
    • Guangzhou, Guangdong, China, 510000
    • Guangzhou, Guangdong, China, 510150
    • Guangzhou, Guangdong, China, 510370
  • Henan
    • Zhengzhou, Henan, China, 450006
  • Hubei
    • Wuhan, Hubei, China, 430022
  • Hunan
    • Changsha, Hunan, China, 410011
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
  • Liaoning
    • Shenyang, Liaoning, China, 110168
  • Shandong
    • Jinan, Shandong, China, 250014
  • Shanghai
    • Shanghai, Shanghai, China, 200003
    • Shanghai, Shanghai, China, 200030
    • Shanghai, Shanghai, China, 200080
    • Shanghai, Shanghai, China, 200083
    • Shanghai, Shanghai, China, 200090
    • Shanghai, Shanghai, China, 200124
    • Shanghai, Shanghai, China, 201900
  • Shanxi
    • Xian, Shanxi, China, 710061
  • Tianjin
    • Tianjin, Tianjin, China, 300350
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
    • Hangzhou, Zhejiang, China, 310013
    • Huzhou, Zhejiang, China, 313000
    • Suzhou, Zhejiang, China, 215008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 1.Effexor XR Group	Drug: Effexor
Active Comparator: 2; 2.SSRI or Conventional Antidepressant Group	Drug: SSRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Achieving Remission	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)	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.	12 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 10, 2007
• First Submitted That Met QC Criteria: May 15, 2007
• First Posted (Estimate): May 17, 2007

Study Record Updates

• Last Update Posted (Estimate): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 2, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: 0600B2-4418