Back to resultsStudy Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
desvenlafaxine succinate sustained-release
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Birmingham Psychiatry Pharmaceutical Studies, Inc.
- Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
- Pacific Clinical Research Medical Group
- Southwestern Research, Inc.
- Catalina Research Institute LLC
- Pacific Clinical Research Medical Group
- Pacific Clinical Research Medical Group
- Western Affiliated Research Institute
- Radiant Research, Inc.
- Connecticut Clinical Research
- Comprehensive NeuroScience, Inc.
- Stedman Clinical Trials, LLC
- Janus Center for Psychiatric Research
- Emory University Department of Psychiatry and Behavioral Sciences
- Atlanta Center for Medical Research
- Northwest Behavioral Research Center
- Carman Research
- Capstone Clinical Research
- Deaconess Clinic Gateway Health Center Research Institute
- Via Christi Research
- Westside Family Medical Center, P.C.
- Radiant Research, Inc.
- Center For Emotional Fitness
- Robert Wood Johnson Medical School
- Social Psychiatry Research Institute
- Medical & Behavioral Health Research PC
- Metrolina Medical Research
- Horizon Medical Services, PC
- Legacy Pharma Research
- North Coast Clinical Trials, Inc.
- Midwest Clinical Research Center
- Summit Research Network (Oregon), Inc.
- Lehigh Center for Clinical Research
- Omega Medical Research
- Carolina Clinical Research Services, LLC
- Holston Medical Group
- Holston Medical Group
- Bayou City Research, Ltd.
- Radiant Research, Inc.
- University of Virginia Health System Center for Psychiatric Clinical Research
- Nelson Clinic
- Northwest Clinical Research Center
- Summit Research Network (Seattle) LLC
- Independent Psychiatric Consultants, SC dba IPC Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
desvenlafaxine succinate sustained-release
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01121484
Brief Title
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
desvenlafaxine succinate sustained-release
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained-release
Other Intervention Name(s)
Pristiq
Intervention Description
50-mg DVS SR tablets taken orally once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablets taken orally once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Description
CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame
Week 8
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Description
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Description
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Description
This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
Description
10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91007-3462
Country
United States
Facility Name
Southwestern Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Catalina Research Institute LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Connecticut Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Comprehensive NeuroScience, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University Department of Psychiatry and Behavioral Sciences
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Deaconess Clinic Gateway Health Center Research Institute
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Via Christi Research
City
Witchita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Westside Family Medical Center, P.C.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Radiant Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Center For Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Medical & Behavioral Health Research PC
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Horizon Medical Services, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Legacy Pharma Research
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
North Coast Clinical Trials, Inc.
City
Beechwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Summit Research Network (Oregon), Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Carolina Clinical Research Services, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Bayou City Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Health System Center for Psychiatric Clinical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Nelson Clinic
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Summit Research Network (Seattle) LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Independent Psychiatric Consultants, SC dba IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34183490
Citation
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.
Results Reference
derived
PubMed Identifier
29140227
Citation
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.
Results Reference
derived
PubMed Identifier
26709542
Citation
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.
Results Reference
derived
PubMed Identifier
26644956
Citation
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.
Results Reference
derived
PubMed Identifier
25860107
Citation
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.
Results Reference
derived
PubMed Identifier
25758058
Citation
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.
Results Reference
derived
PubMed Identifier
24571916
Citation
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.
Results Reference
derived
PubMed Identifier
24229754
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3364&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained-Release%20%28DVS%20SR%29%20In%20The%20Treatment%20Of%20Peri-%20And%20Postmenopausal%20Women%20With%20Major%20De
Description
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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
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