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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474708
• Other study ID #: 0600B2-4418
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2007
• Last updated: March 2, 2012
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 1151
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Effexor

• SSRI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes