Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
NCT ID: NCT00384033
Last Updated: 2012-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
638 participants
INTERVENTIONAL
2006-09-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Desvenlafaxine succinate sustained-release 50 mg
Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine succinate sustained-release 100 mg
Desvenlafaxine Succinate Sustained-Release (DVS SR)
100 mg tablet, once daily dosing for 8 weeks
Placebo
Placebo
Matching placebo tablets and capsules, once daily dosing for 8 weeks
Duloxetine 60mg
Active control to assess assay sensitivity
Duloxetine 60 mg/day
60 mg capsule, once daily dosing for 8 weeks
Interventions
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Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine Succinate Sustained-Release (DVS SR)
100 mg tablet, once daily dosing for 8 weeks
Placebo
Matching placebo tablets and capsules, once daily dosing for 8 weeks
Duloxetine 60 mg/day
60 mg capsule, once daily dosing for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Depressive symptoms for at least 30 days before the screening visit.
* Outpatient men and women at least 18 years of age.
Exclusion Criteria
* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Burbank, California, United States
Pfizer Investigational Site
Encino, California, United States
Pfizer Investigational Site
Los Alamitos, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Northridge, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
St. Petersburg, Florida, United States
Pfizer Investigational Site
Edwardsville, Illinois, United States
Pfizer Investigational Site
Farmington Hills, Michigan, United States
Pfizer Investigational Site
Flint, Michigan, United States
Pfizer Investigational Site
Okemos, Michigan, United States
Pfizer Investigational Site
Clementon, New Jersey, United States
Pfizer Investigational Site
Dayton, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Brown Deer, Wisconsin, United States
Countries
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References
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Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3151A1-335
Identifier Type: -
Identifier Source: org_study_id
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