Vortioxetine for Menopausal Depression

Inclusion Criteria

• Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including:
• Perimenopausal women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician
• Women who are using the Mirena Intrauterine Device (IUD), with Follicle-stimulating hormone (FSH) level > 20 milli-International unit/ml (mIU/mL)
• 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.)
• MADRS scores of at least 20 at baseline visit
• Women with significant menopause-related physical symptoms, indicated by any of the following criteria:
• Greene Climacteric Scale total scores > 20;
• Greene Climacteric Scale sub-score for vasomotor symptoms >3;
• 14 or more bothersome hot flashes per week (self-reported).
• Signed informed consent.

Exclusion Criteria

• Pregnancy (determined by urine pregnancy test), intending pregnancy, or breast feeding.
• 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.
• History of or current mania/hypomania, psychosis, or bipolar disorder
• Regular treatment with an Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitors (SNRI) within 2 months prior to screening visit
• Serious suicidal ideation or intent
• Women who have used psychoactive or centrally acting medications within 2 weeks prior to study screening
• Women who have received hormonal intervention within 1 month prior to study entry
• Known hypersensitivity to vortioxetine or any of the inactive ingredients
• 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
• Treatment with linezolid or intravenous methylene blue
• Patients with severe hepatic impairment
• Uncontrolled hypertension (>160/90 mmHg)
• Resting heart rate >110/minute
• Any current severe or unstable medical illness
• Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
• Drug or alcohol abuse in the past 1 year
• Use of any disallowed medications (specified in the Excluded Concomitant Medication section below)
• 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