Study Evaluating Venlafaxine ER in Recurrent Depression
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
1 other identifier
interventional
1,096
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2000
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 18, 2002
CompletedFirst Posted
Study publicly available on registry
September 19, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 14, 2009
August 1, 2009
5.2 years
September 18, 2002
August 13, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis for recurrent major depression
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Kornstein SG, Pedersen RD, Holland PJ, Nemeroff CB, Rothschild AJ, Thase ME, Trivedi MH, Ninan PT, Keller MB. Influence of sex and menopausal status on response, remission, and recurrence in patients with recurrent major depressive disorder treated with venlafaxine extended release or fluoxetine: analysis of data from the PREVENT study. J Clin Psychiatry. 2014 Jan;75(1):62-8. doi: 10.4088/JCP.12m07841.
PMID: 24345717DERIVEDKeller MB, Trivedi MH, Thase ME, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Kocsis JH, Dunner DL, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen RD, Yan B, Ahmed S, Musgnung J, Ninan PT. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the 2-year and combined maintenance phases. J Clin Psychiatry. 2007 Aug;68(8):1246-56. doi: 10.4088/jcp.v68n0812.
PMID: 17854250DERIVEDKocsis JH, Thase ME, Trivedi MH, Shelton RC, Kornstein SG, Nemeroff CB, Friedman ES, Gelenberg AJ, Dunner DL, Hirschfeld RM, Rothschild AJ, Ferguson JM, Schatzberg AF, Zajecka JM, Pedersen RD, Yan B, Ahmed S, Musgnung J, Ninan PT, Keller MB. Prevention of recurrent episodes of depression with venlafaxine ER in a 1-year maintenance phase from the PREVENT Study. J Clin Psychiatry. 2007 Jul;68(7):1014-23. doi: 10.4088/jcp.v68n0706.
PMID: 17685736DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 18, 2002
First Posted
September 19, 2002
Study Start
August 1, 2000
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
August 14, 2009
Record last verified: 2009-08