ABOUT THIS STUDY
- 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.
- 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.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Nashville, Tennessee
- Madison, Wisconsin
- Vancouver, British Columbia