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

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.