Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder
2 other identifiers
interventional
439
1 country
44
Brief Summary
A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Jun 2010
Shorter than P25 for phase_4 major-depressive-disorder
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
March 30, 2012
CompletedApril 4, 2012
January 1, 2012
1 year
May 3, 2010
February 16, 2012
March 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.
Baseline, Week 8
Secondary Outcomes (5)
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Week 8
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Baseline, Week 8
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Baseline, Week 8
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Baseline, Week 8
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Baseline, Week 8
Study Arms (2)
desvenlafaxine succinate sustained-release
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
50-mg DVS SR tablets taken orally once daily.
Eligibility Criteria
You may qualify if:
- Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
- 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:
- an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
- a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
- a change in duration (absolute change of 2 or more days); or
- 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.
You may not qualify if:
- Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
Pacific Clinical Research Medical Group
Arcadia, California, 91007-3462, United States
Southwestern Research, Inc.
Beverly Hills, California, 90210, United States
Catalina Research Institute LLC
Chino, California, 91710, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Connecticut Clinical Research
Cromwell, Connecticut, 06416, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, 30306, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Carman Research
Smyrna, Georgia, 30080, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Deaconess Clinic Gateway Health Center Research Institute
Newburgh, Indiana, 47630, United States
Via Christi Research
Witchita, Kansas, 67214, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009, United States
Radiant Research, Inc.
Las Vegas, Nevada, 89146, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Medical & Behavioral Health Research PC
New York, New York, 10023, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Horizon Medical Services, PC
Bismarck, North Dakota, 58501, United States
Legacy Pharma Research
Bismarck, North Dakota, 58501, United States
North Coast Clinical Trials, Inc.
Beechwood, Ohio, 44122, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Carolina Clinical Research Services, LLC
Columbia, South Carolina, 29201, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Bayou City Research, Ltd.
Houston, Texas, 77007, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
University of Virginia Health System Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903, United States
Nelson Clinic
Richmond, Virginia, 23298, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Independent Psychiatric Consultants, SC dba IPC Research
Waukesha, Wisconsin, 53188, United States
Related Publications (8)
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.
PMID: 34183490DERIVEDSoares 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.
PMID: 29140227DERIVEDMcIntyre 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.
PMID: 26709542DERIVEDMcIntyre 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.
PMID: 26644956DERIVEDKornstein 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.
PMID: 25860107DERIVEDThase 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.
PMID: 25758058DERIVEDSoares 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.
PMID: 24571916DERIVEDClayton 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.
PMID: 24229754DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Baseline characteristics are available for all treated participants (434) and not all randomized participants (439).
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 12, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 4, 2012
Results First Posted
March 30, 2012
Record last verified: 2012-01