Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
NCT ID: NCT01121484
Last Updated: 2012-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
439 participants
INTERVENTIONAL
2010-06-30
2011-06-30
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
desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
Placebo
placebo
Placebo tablets taken orally once daily.
Interventions
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desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
placebo
Placebo tablets taken orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level \>40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
3. a change in duration (absolute change of 2 or more days); or
4. periods of amenorrhea lasting at least 3 months.
* A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
* A Montgomery and Asberg Depression Rating Scale (MADRS) total score \>=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.
Exclusion Criteria
* Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of \>=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
* Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
40 Years
70 Years
FEMALE
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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Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
Arcadia, California, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Catalina Research Institute LLC
Chino, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Radiant Research, Inc.
Denver, Colorado, United States
Connecticut Clinical Research
Cromwell, Connecticut, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Roswell, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Deaconess Clinic Gateway Health Center Research Institute
Newburgh, Indiana, United States
Via Christi Research
Witchita, Kansas, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States
Radiant Research, Inc.
Las Vegas, Nevada, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, United States
Robert Wood Johnson Medical School
Piscataway, New Jersey, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Medical & Behavioral Health Research PC
New York, New York, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Horizon Medical Services, PC
Bismarck, North Dakota, United States
Legacy Pharma Research
Bismarck, North Dakota, United States
North Coast Clinical Trials, Inc.
Beechwood, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Carolina Clinical Research Services, LLC
Columbia, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
University of Virginia Health System Center for Psychiatric Clinical Research
Charlottesville, Virginia, United States
Nelson Clinic
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Independent Psychiatric Consultants, SC dba IPC Research
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.
Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
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.
Clayton AH, Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W, Ninan PT. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065.
Related Links
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Other Identifiers
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B2061029
Identifier Type: -
Identifier Source: secondary_id
3151A1-3364
Identifier Type: -
Identifier Source: org_study_id
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