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
1 other identifier
interventional
1,151
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Apr 2007
Shorter than P25 for phase_4 major-depressive-disorder
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 10, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
April 30, 2010
CompletedMarch 5, 2012
March 1, 2012
11 months
May 10, 2007
March 31, 2009
March 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
12 weeks
Study Arms (2)
1
EXPERIMENTAL1.Effexor XR Group
2
ACTIVE COMPARATOR2.SSRI or Conventional Antidepressant Group
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Beijing, Beijing Municipality, 100080, China
Unknown Facility
Beijing, Beijing Municipality, 100083, China
Unknown Facility
Beijing, Beijing Municipality, 100096, China
Unknown Facility
Guangzhou, Guangdong, 510000, China
Unknown Facility
Guangzhou, Guangdong, 510080, China
Unknown Facility
Guangzhou, Guangdong, 510150, China
Unknown Facility
Guangzhou, Guangdong, 510370, China
Unknown Facility
Zhengzhou, Henan, 450006, China
Unknown Facility
Wuhan, Hubei, 430022, China
Unknown Facility
Changsha, Hunan, 410011, China
Unknown Facility
Nanjing, Jiangsu, 210029, China
Unknown Facility
Shenyang, Liaoning, 110168, China
Unknown Facility
Jinan, Shandong, 250014, China
Unknown Facility
Shanghai, Shanghai Municipality, 200003, China
Unknown Facility
Shanghai, Shanghai Municipality, 200030, China
Unknown Facility
Shanghai, Shanghai Municipality, 200080, China
Unknown Facility
Shanghai, Shanghai Municipality, 200083, China
Unknown Facility
Shanghai, Shanghai Municipality, 200090, China
Unknown Facility
Shanghai, Shanghai Municipality, 200124, China
Unknown Facility
Shanghai, Shanghai Municipality, 201900, China
Unknown Facility
Xian, Shanxi, 710061, China
Unknown Facility
Tianjin, Tianjin Municipality, 300350, China
Unknown Facility
Hangzhou, Zhejiang, 310000, China
Unknown Facility
Hangzhou, Zhejiang, 310013, China
Unknown Facility
Huzhou, Zhejiang, 313000, China
Unknown Facility
Suzhou, Zhejiang, 215008, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
365 participants were assessed for safety. Certain demographic data (gender and age) is missing for one participant. Thereby resulting in the participant flow reflecting 364 participants.
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2007
First Posted
May 17, 2007
Study Start
April 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
March 5, 2012
Results First Posted
April 30, 2010
Record last verified: 2012-03