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

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT01121484

Run by

Pfizer

People needed

439

Starts

2010-06-01

Expected to finish

2011-06-01

Last updated by the study team

2012-04-04

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Birmingham Psychiatry Pharmaceutical Studies, Inc. — Birmingham, Alabama, United States
• Arkansas Psychiatric Clinic Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
• Pacific Clinical Research Medical Group — Arcadia, California, United States
• Southwestern Research, Inc. — Beverly Hills, California, United States
• Catalina Research Institute LLC — Chino, California, United States
• Pacific Clinical Research Medical Group — Orange, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Western Affiliated Research Institute — Denver, Colorado, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Connecticut Clinical Research — Cromwell, Connecticut, United States
• Comprehensive NeuroScience, Inc. — St. Petersburg, Florida, United States
• Stedman Clinical Trials, LLC — Tampa, Florida, United States
• Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
• Emory University Department of Psychiatry and Behavioral Sciences — Atlanta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Northwest Behavioral Research Center — Roswell, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Deaconess Clinic Gateway Health Center Research Institute — Newburgh, Indiana, United States
• Via Christi Research — Witchita, Kansas, United States
• Westside Family Medical Center, P.C. — Kalamazoo, Michigan, United States
• Radiant Research, Inc. — Las Vegas, Nevada, United States
• Center For Emotional Fitness — Cherry Hill, New Jersey, United States
• Robert Wood Johnson Medical School — Piscataway, New Jersey, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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