Clinical trial NCT00474708: Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 1151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Patients Achieving Remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Beijing
country: China
state: Beijing
city: Beijing
country: China
state: Beijing
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Zhengzhou
country: China
state: Henan
city: Wuhan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Shenyang
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Shanghai
country: China
state: Shanghai
city: Xian
country: China
state: Shanxi
city: Tianjin
country: China
state: Tianjin
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Huzhou
country: China
state: Zhejiang
city: Suzhou
country: China
state: Zhejiang
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: