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

March 30, 2012 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: placebo
Placebo tablets taken orally once daily.
EXPERIMENTAL: desvenlafaxine succinate sustained-release
Drug: desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
Other Names:
  • Pristiq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 8
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.
Baseline, Week 8
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.
Baseline, Week 8
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.
Baseline, Week 8
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.
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A1-3364
  • B2061029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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