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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Beijing, Beijing, 100080 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00474708
Pfizer
Completed
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

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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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Effexor
  • Drug: SSRI
  • Experimental: 1
    1.Effexor XR Group
    Intervention: Drug: Effexor
  • Active Comparator: 2
    2.SSRI or Conventional Antidepressant Group
    Intervention: Drug: SSRI
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1151
March 2008
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00474708
0600B2-4418
Yes
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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