Vortioxetine for the Treatment of Major Depression and Co-morbidities After Traumatic Brain Injury (TBI)

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2016

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
TBIMajor Depression
Interventions
DRUG

Vortioxetine

The study drug, vortioxetine received approval from the U.S. Food and Drug Administration (FDA) to treat adults with major depressive disorder. This study is being done to determine its effectiveness in a specialized population, i.e. those who have developed major depression after a traumatic brain injury. As patients who have sustained a TBI are medically fragile and sensitive to side-effects of medications, it is important to test the effectiveness and safety of vortioxetine in this population.

DRUG

Placebo

A placebo comparator will be used in one subset of patients.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Johns Hopkins University

OTHER