Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: desvenlafaxine 50 mg (Drug); desvenlafaxine 100 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Estonia, Latvia, Lithuania, WPVIMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Romania, WPVIMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Finland, MedInfoNord@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Croatia, WPBUMED@wyeth.com Trial Manager, Principal Investigator, Affiliation: For South Africa, ZAFinfo@wyeth.com Trial Manager, Principal Investigator, Affiliation: For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com
Summary
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of
DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives
include testing both general and functional quality-of-life outcomes and satisfaction with
therapy reported by the subject.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
Secondary outcome: The Global Clinical Improvement will be the key secondary efficacy variable.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A primary diagnosis of MDD
- Depressive symptoms for at least 30 days before the screening visit.
Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- Known hypersensitivity to venlafaxine
- Significant risk of suicide based on clinical judgment
Locations and Contacts
Rijeka 51000, Croatia
Split 21000, Croatia
Zagreb 10090, Croatia
Tallinn 126 18, Estonia
Tartu 50407, Estonia
Tartu 50417, Estonia
Espoo FIN-02650, Finland
Helsinki FIN-00530, Finland
Helsinki FIN-00260, Finland
Helsinki FIN-00100, Finland
Joensuu 80100, Finland
Kuopio 70110, Finland
Oulu 90 100, Finland
Rauma 26100, Finland
Salo 24100, Finland
Turku SF-20100, Finland
Caen 14000, France
Dole 39100, France
Douai 59500, France
Mulhouse 68100, France
Orvault 44700, France
Rennes 35000, France
Tours 37300, France
Jelgava 3008, Latvia
Liepaja 3401, Latvia
Riga 1005, Latvia
Strenci 4730, Latvia
Kaunas 50185, Lithuania
Klaipeda 91251, Lithuania
Vilnius 10204, Lithuania
Lubiaz 56-100, Poland
Tuszyn 95 080, Poland
Zuromin 09-300, Poland
Bucuresti 41914, Romania
Bucuresti 60011, Romania
Craiova 200738, Romania
Bojnice 97201, Slovakia
Bratislava 82606, Slovakia
Rimavska Sobota 97901, Slovakia
Bloemfontein 9301, South Africa
Cape Town 9646, South Africa
Durban 4058, South Africa
Pretoria 157, South Africa
Additional Information
Starting date: March 2006
Last updated: December 3, 2007
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