Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained-release; placebo
Intervention description: 50-mg DVS SR tablets taken orally once daily.; Placebo tablets taken orally once daily.
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 439.0
Sex: Female
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        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.