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

Last updated on November 17, 2019

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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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Effexor
  • Drug: SSRI
Study Arms  ICMJE
  • Experimental: 1
    1.Effexor XR Group
    Intervention: Drug: Effexor
  • Active Comparator: 2
    2.SSRI or Conventional Antidepressant Group
    Intervention: Drug: SSRI
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2010)
1151
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2007)
1200
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion DateMarch 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474708
Other Study ID Numbers  ICMJE 0600B2-4418
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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