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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121484
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : March 30, 2012
Last Update Posted : April 4, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: desvenlafaxine succinate sustained-release Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: desvenlafaxine succinate sustained-release Drug: desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
Other Name: Pristiq

Placebo Comparator: Placebo Drug: placebo
Placebo tablets taken orally once daily.

Primary Outcome Measures :
  1. Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 [ Time Frame: Baseline, 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 :
  1. Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 8 ]
    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.

  2. Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 [ Time Frame: Baseline, 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.

  3. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 [ Time Frame: Baseline, 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.

  4. Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) [ Time Frame: Baseline, Week 8 ]
    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.

  5. Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 [ Time Frame: Baseline, 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121484

  Hide Study Locations
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United States, Alabama
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
United States, Arkansas
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States, 72223
United States, California
Pacific Clinical Research Medical Group
Arcadia, California, United States, 91007-3462
Southwestern Research, Inc.
Beverly Hills, California, United States, 90210
Catalina Research Institute LLC
Chino, California, United States, 91710
Pacific Clinical Research Medical Group
Orange, California, United States, 92868
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
United States, Colorado
Western Affiliated Research Institute
Denver, Colorado, United States, 80209
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Connecticut
Connecticut Clinical Research
Cromwell, Connecticut, United States, 06416
United States, Florida
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States, 33716
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States, 30306
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Northwest Behavioral Research Center
Roswell, Georgia, United States, 30076
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
United States, Indiana
Deaconess Clinic Gateway Health Center Research Institute
Newburgh, Indiana, United States, 47630
United States, Kansas
Via Christi Research
Witchita, Kansas, United States, 67214
United States, Michigan
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States, 49009
United States, Nevada
Radiant Research, Inc.
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Center For Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
United States, New York
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
Medical & Behavioral Health Research PC
New York, New York, United States, 10023
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
United States, North Dakota
Horizon Medical Services, PC
Bismarck, North Dakota, United States, 58501
Legacy Pharma Research
Bismark, North Dakota, United States, 58501
United States, Ohio
North Coast Clinical Trials, Inc.
Beechwood, Ohio, United States, 44122
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oregon
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Carolina Clinical Research Services, LLC
Columbia, South Carolina, United States, 29201
United States, Tennessee
Holston Medical Group
Bristol, Tennessee, United States, 37620
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Bayou City Research, Ltd.
Houston, Texas, United States, 77007
Radiant Research, Inc.
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Health System Center for Psychiatric Clinical Research
Charlottesville, Virginia, United States, 22903
Nelson Clinic
Richmond, Virginia, United States, 23298
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle) LLC
Seattle, Washington, United States, 98104
United States, Wisconsin
Independent Psychiatric Consultants, SC dba IPC Research
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Pfizer Identifier: NCT01121484     History of Changes
Other Study ID Numbers: 3151A1-3364
First Posted: May 12, 2010    Key Record Dates
Results First Posted: March 30, 2012
Last Update Posted: April 4, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs