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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1.Effexor XR Group

Group Type EXPERIMENTAL

Effexor

Intervention Type DRUG

2

2.SSRI or Conventional Antidepressant Group

Group Type ACTIVE_COMPARATOR

SSRI

Intervention Type DRUG

Interventions

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Effexor

Intervention Type DRUG

SSRI

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Beijing, Beijing Municipality, China

Site Status

Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Guangzhou, Guangdong, China

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Zhengzhou, Henan, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Shenyang, Liaoning, China

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Jinan, Shandong, China

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