CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Vortioxetine 10 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/NCT02637895
NCT02637895Phase 4Completed
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Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder

University of Miami·interventional·Posted Dec 22, 2015·Updated Feb 8, 2021

In Brief

A Phase 4 clinical trial evaluating Placebo and Vortioxetine for Post-Traumatic Stress Disorder. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

Post-traumatic stress disorder (PTSD) can result from having experienced or witnessed a traumatic event. Patients with PTSD symptoms can sometimes experience symptom relief after treatment with antidepressants; however, few patients experience complete symptom relief. There is a need to develop new treatments for PTSD. This study will evaluate if 12 weeks of using Vortioxetine relieves PTSD symptoms. Vortioxetine has been approved for the treatment of depression; however, Vortioxetine has not been approved by the Food and Drug Administration for the treatment of PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Traumatic Stress Disorder
CountriesUnited States
CollaboratorsTakeda, Emory University

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartDec 1, 2016
Primary CompletionJan 22, 2020
Study CompletionFeb 6, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.5 years ago

Interventions

Placebodrug

Placebo pill matching Vortioxetine.

Vortioxetinedrug

Immediate Release 10 mg. Vortioxetine Pill