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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Effexor
SSRI
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

1.Effexor XR Group

2.SSRI or Conventional Antidepressant Group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2007
Last Updated
March 2, 2012
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00474708
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1.Effexor XR Group
Arm Title
2
Arm Type
Active Comparator
Arm Description
2.SSRI or Conventional Antidepressant Group
Intervention Type
Drug
Intervention Name(s)
Effexor
Intervention Type
Drug
Intervention Name(s)
SSRI
Primary Outcome Measure Information:
Title
Number of Patients Achieving Remission
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100080
Country
China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110168
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200083
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200124
Country
China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201900
Country
China
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
City
Suzhou
State/Province
Zhejiang
ZIP/Postal Code
215008
Country
China

12. IPD Sharing Statement

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

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