CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
vortioxetinedrug
Likely dose
vortioxetine 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02234362
NCT02234362Phase 4Completed
CompareCT.gov

Vortioxetine for Menopausal Depression and Associated Symptoms

Massachusetts General Hospital·interventional·Posted Sep 9, 2014·Updated Jun 28, 2017

In Brief

A Phase 4 clinical trial evaluating vortioxetine for Depression and 4 related conditions. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Menopause, Vasomotor Disturbance, Hot Flashes, Sleep
CountriesUnited States
CollaboratorsTakeda Pharmaceuticals North America, Inc.

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartJun 12, 2015
Primary CompletionSep 29, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

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.