Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
NCT ID: NCT00863798
Last Updated: 2011-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
682 participants
INTERVENTIONAL
2009-04-30
2010-03-31
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 10 mg
Desvenlafaxine Succinate Sustained-Release 10mg
10 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine succinate sustained release 50 mg
Desvenlafaxine Succinate Sustained-Release 50 mg
50 mg tablet, once daily dosing for 8 weeks
Placebo
placebo
Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Interventions
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Desvenlafaxine Succinate Sustained-Release 10mg
10 mg tablet, once daily dosing for 8 weeks
Desvenlafaxine Succinate Sustained-Release 50 mg
50 mg tablet, once daily dosing for 8 weeks
placebo
Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
Eligibility Criteria
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Inclusion Criteria
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20.
* Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4.
Exclusion Criteria
* Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Encino, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Redlands, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Cromwell, Connecticut, United States
Pfizer Investigational Site
Maitland, Florida, United States
Pfizer Investigational Site
North Miami, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Staten Island, New York, United States
Pfizer Investigational Site
Toledo, Ohio, United States
Pfizer Investigational Site
Eugene, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Salem, Oregon, United States
Pfizer Investigational Site
Media, Pennsylvania, United States
Pfizer Investigational Site
Herndon, Virginia, United States
Pfizer Investigational Site
Midlothian, Virginia, United States
Pfizer Investigational Site
Middleton, Wisconsin, United States
Pfizer Investigational Site
Waukesha, 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.
Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.
Related Links
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Other Identifiers
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B2061005
Identifier Type: -
Identifier Source: secondary_id
3151A1-3362-US
Identifier Type: -
Identifier Source: secondary_id
3151A1-3362
Identifier Type: -
Identifier Source: org_study_id
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