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Vortioxetine for Posttraumatic Stress Disorder

NCT02637895 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-02-08

Study results available
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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.

Conditions

  • Post-Traumatic Stress Disorder

Interventions

DRUG

Placebo

Placebo pill matching Vortioxetine.

DRUG

Vortioxetine

Immediate Release 10 mg. Vortioxetine Pill

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Emory University

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Philip Harvey, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-01-22
Completion
2020-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637895 on ClinicalTrials.gov