- 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.