NCT02637895

Vortioxetine for Posttraumatic Stress Disorder

Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients included in the study will either take the study medication or will take a placebo, a pill without the active medication. This will be determined by chance like a flip of a coin. Study procedures will include taking study medication and coming to regular in-clinic visits. Depending on the study visit, study tests may include the following: medical evaluations, physical exams, body measurements, vital signs, blood and urine tests, pregnancy tests, genetic testing, heart function monitoring, clinical and psychiatric measures, neuropsychological testing (for example, investigators will test how well you remember words or how fast you perform a certain task), a function test (for example, investigators will test how well you perform certain daily tasks), and a test to measure your startle response. A startle response is an unexpected response by a sudden activity.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Placebo pill matching Vortioxetine.
DRUG	Vortioxetine	Immediate Release 10 mg. Vortioxetine Pill

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-01-22
• Completion: 2020-02-06
• First posted: 2015-12-22
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study