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CompletedNCT01121484Updated Apr 4, 2012Results posted

Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

A Phase 4 interventional study of desvenlafaxine succinate sustained-release and placebo in Major Depressive Disorder, sponsored by Pfizer. Completed at 44 sites in United States. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-04-04.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
439
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 439 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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:

    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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
439 participants (actual)

Study arms

  • Experimental
    desvenlafaxine succinate sustained-release

    Drug: desvenlafaxine succinate sustained-release

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • Drugdesvenlafaxine succinate sustained-release

    50-mg DVS SR tablets taken orally once daily.

    Also known as: Pristiq

  • Drugplacebo

    Placebo tablets taken orally once daily.

06

What researchers measure

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.

    Time frame: Baseline, Week 8

Secondary outcomes

  1. 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.

    Time frame: Week 8

  2. 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.

    Time frame: Baseline, Week 8

  3. 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.

    Time frame: Baseline, Week 8

  4. 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.

    Time frame: Baseline, Week 8

  5. 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.

    Time frame: Baseline, Week 8

07

Results

Posted Mar 30, 2012
Limitations and caveats
Baseline characteristics are available for all treated participants (434) and not all randomized participants (439).

Participant flow

Participant flow — Overall Study
MilestoneDesvenlafaxine SuccinatePlacebo
Started218221
Treated217217
Completed185178
Not completed3343
Withdrew: Adverse event125
Withdrew: Lack of efficacy311
Withdrew: Lost to follow-up59
Withdrew: Physician decision03
Withdrew: Protocol violation10
Withdrew: Withdrawal by subject87
Withdrew: Discontinuation of study by sponsor01
Withdrew: Other33
Withdrew: Randomized, not treated14

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Units on a scale
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
Units on a scaleDesvenlafaxine SuccinatePlacebo
Baseline22.8 ± 3.2922.4 ± 3.51
Change at Week 8-9.7 ± 6.54-7.4 ± 6.74
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · ANCOVA · p = 0.004 (Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.)
SecondaryNumber 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.

Time frame:
Week 8
Reported as:
Number · participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
participantsDesvenlafaxine SuccinatePlacebo
Very Much Improved5139
Much Improved6737
Minimally Improved5362
No Change3769
Minimally Worse66
Much Worse23
Very Much Worse00
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · Cochran-Mantel-Haenszel · p = <0.001 (CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.)
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Units on a scale
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
Units on a scaleDesvenlafaxine SuccinatePlacebo
Baseline4.4 ± 0.604.3 ± 0.53
Change at Week 8-1.5 ± 1.20-1.1 ± 1.24
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · ANCOVA · p = 0.002 (Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.)
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Units on a scale
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
Units on a scaleDesvenlafaxine SuccinatePlacebo
Baseline31.0 ± 3.7630.6 ± 3.83
Change at Week 8-14.8 ± 9.09-11.6 ± 9.99
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · ANCOVA · p = 0.002 (Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.)
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · Units on a scale
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
Units on a scaleDesvenlafaxine SuccinatePlacebo
Baseline15.1 ± 3.2214.8 ± 3.60
Change at Week 8-5.9 ± 4.93-5.2 ± 4.48
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · ANCOVA · p = 0.158 (Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.)
SecondaryChange 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.

Time frame:
Baseline, Week 8
Reported as:
Mean · cm
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
cmDesvenlafaxine SuccinatePlacebo
Baseline4.0 ± 2.904.0 ± 2.98
Change at Week 8-1.5 ± 2.69-0.8 ± 2.72
Statistical analysis
  • Desvenlafaxine Succinate vs Placebo · ANCOVA · p = <0.001 (Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Desvenlafaxine Succinate—2/217 (0.9%)100/217 (46.1%)
Placebo—2/217 (0.9%)90/217 (41.5%)
Most frequent serious events
Most frequent serious events
EventDesvenlafaxine SuccinatePlacebo
Non-Cardiac Chest PainGeneral disorders1/2170/217
Head InjuryInjury, poisoning and procedural complications0/2171/217
LeukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2171/217
Cerebrovascular AccidentNervous system disorders1/2170/217
Subarachnoid HaemorrhageNervous system disorders1/2170/217
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/2170/217
Aneurysm RupturedVascular disorders1/2170/217
Most frequent other events
Most frequent other events
EventDesvenlafaxine SuccinatePlacebo
HeadacheNervous system disorders33/21725/217
NauseaGastrointestinal disorders24/21716/217
Upper Respiratory Tract InfectionInfections and infestations17/21719/217
ConstipationGastrointestinal disorders17/2179/217
Dry MouthGastrointestinal disorders14/21717/217
NasopharyngitisInfections and infestations15/21712/217
DizzinessNervous system disorders14/21710/217
DiarrhoeaGastrointestinal disorders13/21712/217

Baseline characteristics

Age Continuous
Age Continuous(Years)Desvenlafaxine SuccinatePlaceboTotal
Mean53.1 ± 6.8552.8 ± 6.5853.0 ± 6.71
Sex: Female, Male
Sex: Female, Male(Participants)Desvenlafaxine SuccinatePlaceboTotal
Female217217434
Male000
08

Study locations

44 sites
  • 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
    Bismark, 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
09

References and documents

Publications

  • 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. PubMed 34183490 ↗
  • 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. PubMed 29140227 ↗
  • 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. PubMed 26709542 ↗
  • 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. PubMed 26644956 ↗
  • 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. PubMed 25860107 ↗
  • 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. PubMed 25758058 ↗
  • 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. PubMed 24571916 ↗
  • 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. PubMed 24229754 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01121484
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 12, 2010
Start date
Jun 2010
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Mar 30, 2012
Last update
Apr 4, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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