Vortioxetine for Menopausal Depression

Massachusetts General Hospital47 enrolled

Overview

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.

Forty-seven peri- and postmenopausal women were enrolled in this open-label study. This was an 8-week intervention using open-label vortioxetine with flexible dose between 5-20 mg, dependent on participant response and tolerability. In addition to assessment of depressive symptoms, improvement of menopause-related physical and emotional symptoms that occur with MDD, including vasomotor symptoms, cognition, fatigue, anxiety, sleep complaints, and quality of life, were also examined.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Menopause Vasomotor Disturbance Hot Flashes Sleep

Interventions

vortioxetineDRUG

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 62 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)

The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.