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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Effexor (Drug); SSRI (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Clinical Details

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

Primary outcome: Number of Patients Achieving Remission

Secondary outcome: Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Beijing, Beijing 100083, China

Beijing, Beijing 100096, China

Beijing, Beijing 100080, China

Guangzhou, Guangdong 510370, China

Guangzhou, Guangdong 510000, China

Guangzhou, Guangdong 510150, China

Guangzhou, Guangdong 510080, China

Zhengzhou, Henan 450006, China

Wuhan, Hubei 430022, China

Changsha, Hunan 410011, China

Nanjing, Jiangsu 210029, China

Shenyang, Liaoning 110168, China

Jinan, Shandong 250014, China

Shanghai, Shanghai 200003, China

Shanghai, Shanghai 200030, China

Shanghai, Shanghai 200080, China

Shanghai, Shanghai 200083, China

Shanghai, Shanghai 200090, China

Shanghai, Shanghai 200124, China

Shanghai, Shanghai 201900, China

Xian, Shanxi 710061, China

Tianjin, Tianjin 300350, China

Hangzhou, Zhejiang 310000, China

Hangzhou, Zhejiang 310013, China

Huzhou, Zhejiang 313000, China

Suzhou, Zhejiang 215008, China

Additional Information

Starting date: April 2007
Last updated: March 2, 2012

Page last updated: August 23, 2015

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