CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 123 enrolled
Drug / intervention
Vortioxetinedrug
Likely dose
Vortioxetine tablet, flexible dose (specific dose not stated in available text)AI-extracted
Key inclusion· 5
  • ✓Diagnosis of Major Depressive Disorder as primary psychiatric diagnosis
  • ✓Prior antidepressant treatment for 6 weeks or longer at adequate therapeutic dose
  • ✓Antidepressant treatment ongoing at Screening or discontinued within 6 weeks prior to Screening
  • ✓Investigator considers patient appropriate for antidepressant medication change
Key exclusion· 12
  • ✕Prior antidepressant discontinued more than 6 weeks before Screening
  • ✕At imminent risk for hospitalization due to severe depression; or hospitalized for MDD within 3 months prior to Screening
  • ✕Significant suicide risk per investigator judgment, or suicide attempt in past 6 months, or endorses suicidal ideation items 4 or 5 on C-SSRS in past 6 months
  • ✕Treatment-resistant depression: ≥2 failed adequate antidepressant monotherapy trials (≥6 weeks each) in current episode, or history of response only to combination/augmentation therapy in prior episodes

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

Search/NCT02972632
NCT02972632Phase 4Completed
CompareCT.gov

An Open-Label, Single-Arm, Multicenter, Prospective, Phase 4, Interventional, Flexible Dose Study to Evaluate the Effectiveness of Vortioxetine on Goal Achievement After a Change in Antidepressant Medication for the Treatment of Subjects With Major Depressive Disorder

Takeda·interventional·Posted Nov 23, 2016·Updated Jul 11, 2019

In Brief

A Phase 4 clinical trial evaluating Vortioxetine for Major Depressive Disorder. Completed, enrolled 123 participants across 25 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness of treatment with vortioxetine on participant goal achievement after a change in antidepressant medication for the treatment of major depressive disorder (MDD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartDec 22, 2016
Primary CompletionFeb 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.6 years ago

Interventions

Vortioxetinedrug

Vortioxetine tablet