DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017