ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Clinical diagnosis for recurrent major depression
- 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
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Descriptive Information | ||||
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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 Summary | The 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 Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Venlafaxine ER | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
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* 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 | 1096 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | October 2005 | |||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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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 Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00046020 | |||
Other Study ID Numbers ICMJE | 0600B-100469 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |