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Study Evaluating Venlafaxine ER in Recurrent Depression

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NCT00046020

Last updated on October 11, 2019
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder, Recurrence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis for recurrent major depression

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

- The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine
ER during the current episode of major depression or the patient is
treatment-resistant

- Known hypersensitivity to venlafaxine or fluoxetine

- History or presence of clinically significant hepatic, cardiovascular or renal
disease, or other serious medical disease, including history of seizure disorder

NCT00046020
Pfizer
Completed
Study Evaluating Venlafaxine ER in Recurrent Depression

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information
Brief Title  ICMJE Study Evaluating Venlafaxine ER in Recurrent Depression
Official Title  ICMJE An Acute and Continuation Phase Study of the Comparative Efficacy Study of Venlafaxine ER (Effexor® XR) and Fluoxetine (Prozac®) in Achieving and Sustaining Remission (Wellness) in Patients With Recurrent Unipolar Major Depression; Followed by a Long Term Randomized, Placebo-Controlled Maintenance Treatment Study in Patients Treated Initially With Venlafaxine ER
Brief SummaryThe purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder, Major
  • Recurrence
Intervention  ICMJE Drug: Venlafaxine ER
Study Arms  ICMJE Not Provided
Publications *


*   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: August 13, 2009)		1096
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion DateOctober 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Clinical diagnosis for recurrent major depression

Exclusion Criteria

  • The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine ER during the current episode of major depression or the patient is treatment-resistant
  • Known hypersensitivity to venlafaxine or fluoxetine
  • History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT00046020
Other Study ID Numbers  ICMJE 0600B-100469
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2009

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

BY EMAIL

Contact

[email protected]

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