NCT02234362

Vortioxetine for Menopausal Depression

Vortioxetine for Menopausal Depression and Associated Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 62 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Depression
• Menopause
• Vasomotor Disturbance
• Hot Flashes
• Sleep

Interventions

Type	Name	Description
DRUG	vortioxetine	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.

Timeline

• Start date: 2015-06-12
• Primary completion: 2016-09-29
• Completion: 2016-09-29
• First posted: 2014-09-09
• Last updated: 2017-06-28
• Results posted: 2017-05-02

Locations

1 site across 1 country: United States