CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
vortioxetinedrug
Likely dose
Flexible-dose vortioxetine (specific dose range not specified)AI-extracted
Key inclusion· 5
  • ✓Confirmed MDD (single or recurrent) as primary diagnosis per DSM-IV-TR criteria using MINI v6.0.0
  • ✓Current depressive episode duration 3–24 months
  • ✓MADRS total score ≥26
  • ✓Subject reports subjective cognitive dysfunction (concentration, thinking speed, learning, memory)
Key exclusion· 11
  • ✕Prior inadequate response to or intolerance of vortioxetine
  • ✕DSST score ≥70 at baseline (indicates preserved cognitive function)
  • ✕Current depressive episode considered treatment-resistant (≥2 failed adequate antidepressant trials of ≥6 weeks at recommended dose)
  • ✕Significant suicide risk per PI clinical judgment

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

Search/NCT02749721
NCT02749721Phase 4Completed
CompareCT.gov

Relationship Among Changes in Brain Network Activation, Changes in Core Depressive and Cognitive Symptoms and Safety and Tolerability in Adults With Major Depressive Disorder Treated With Open-Label, Flexible-Dose Vortioxetine

Rush University Medical Center·interventional·Posted Apr 25, 2016·Updated Oct 4, 2021

In Brief

A Phase 4 clinical trial evaluating vortioxetine for Major Depressive Disorder. Completed, enrolled 31 participants across 2 sites.

Detailed Summary

The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD) and 2) improvement of cognitive dysfunction with acute treatment with flexible dose vortioxetine in adult outpatients with MDD and subjective complaints of cognitive dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsTakeda Pharmaceuticals North America, Inc., ElMindA Ltd

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartDec 1, 2016
Primary CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.2 years ago

Interventions

vortioxetinedrug

Open-label vortioxetine