Vortioxetine for Menopausal Depression
Condition: Depression; Menopause; Vasomotor Disturbance; Hot Flashes; Sleep
MeSH terms: Hot Flashes; Depression; Depressive Disorder
Intervention: vortioxetine
Intervention description: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 40 Years
Maximum age: 62 Years
Healthy volunteers: No

Summary:

      The broad goal of this study was to examine the efficacy and tolerability of vortioxetine
      (flexible dose) for the treatment of major depressive disorder (MDD) in symptomatic women
      around the menopausal transition. We hypothesized that an eight-week treatment with
      vortioxetine would promote a significant improvement of depression symptoms and other
      menopause-related physical symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years
             of the last menstrual period if not surgically postmenopausal), including:

               1. Perimenopausal women who have experienced changes in menstrual cycle frequency or
                  duration, and/or physical symptoms indicative of menopausal transition, as
                  determined by clinician

               2. Women who are using the Mirena Intrauterine Device (IUD), with
                  Follicle-stimulating hormone (FSH) level > 20 milli-International unit/ml
                  (mIU/mL)

          2. Women meeting Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)
             criteria for major depression (assessed by the Mini International Neuropsychiatric
             Interview - M.I.N.I.)

          3. MADRS scores of at least 20 at baseline visit

          4. Women with significant menopause-related physical symptoms, indicated by any of the
             following criteria:

               1. Greene Climacteric Scale total scores > 20;

               2. Greene Climacteric Scale sub-score for vasomotor symptoms >3;

               3. 14 or more bothersome hot flashes per week (self-reported).

          5. Signed informed consent.

        Exclusion Criteria:

          1. Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast
             feeding.

          2. Women whose primary diagnosis is Panic Disorder, Obsessive Compulsive Disorder (OCD),
             Generalized Anxiety Disorder (GAD), Seasonal Affective Disorder (SAD), or any other
             Axis I pathology active within 6 months prior to screening visit (except for specific
             phobias). Anxiety disorders are allowable if secondary to MDD as the primary
             diagnosis.

          3. History of or current mania/hypomania, psychosis, or bipolar disorder

          4. Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective
             Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit

          5. Serious suicidal ideation or intent

          6. Women who have used psychoactive or centrally acting medications within 2 weeks prior
             to study screening

          7. Women who have received hormonal intervention within 1 month prior to study entry

          8. Known hypersensitivity to vortioxetine or any of the inactive ingredients

          9. Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or
             potential need to use an MAOI during the study or within 21 days of discontinuation of
             study drug

         10. Treatment with linezolid or intravenous methylene blue

         11. Patients with severe hepatic impairment

         12. Uncontrolled hypertension (>160/90 mmHg)

         13. Resting heart rate >110/minute

         14. Any current severe or unstable medical illness

         15. Not using a medically approved method of birth control, if sexually active and not 12
             or more months since last menstrual period

         16. Drug or alcohol abuse in the past 1 year

         17. Use of any disallowed medications (specified in the Excluded Concomitant Medication
             section below)

         18. Concurrent enrollment in another clinical trial

        Excluded Concomitant Medications:

          -  Selective estrogen-receptor modulators (SERMs)

          -  Hormone replacement therapy

          -  Hormonal contraceptives, excluding Mirena IUD

          -  Natural menopause supplements

          -  Episodic sleep medications (chronic, regular, stable-dose benzodiazepines are allowed)

          -  Antidepressants

          -  Phytoestrogens

          -  Soy-based medications

          -  Steroids

          -  Anorectics, appetite depressants