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