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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Placebo pill matching Vortioxetine.
Immediate Release 10 mg. Vortioxetine Pill
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Change Clinician Administered PTSD Scale Score
Clinician-Administered PTSD Scale (CAPS-5) has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity.
Time frame: Baseline, Up to Week 12
Number of Participants That Achieve Treatment Response Via Clinician Administered PTSD Scale (CAPS)-5
Number of participants that achieve treatment response will be reported as those that has achieved a 30% improvement in their CAPS-5 total score from baseline. CAPS-5 has a total score ranging from 0-80 with the higher score indicating greater degree of PTSD symptom severity. Observed cases only.
Time frame: Week 12
Change in Depressive Symptoms in PTSD
Montgomery-Asberg Depression Rating Scale (MADRS) has a total score ranging from 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.(MADRS). From the total score 0-60, with 0 meaning no depressive symptoms and 60 meaning severe depressive symptoms.
Time frame: Baseline, Up to Week 12
Number of Participants That Achieve Treatment Response Via CGI-I
Clinical Global Impression of Improvement (CGI-I) is a 7 point Likert-scale questionnaire assessing PTSD symptoms improvement. A score of 1 indicates very much improved, 4 indicates no change and 7 indicates much worse. Treatment response will be reported as the number of participants with an improvement of 1-2 points on their CGI-I score from baseline. Analysis includes observed cases only.
Time frame: Week 12
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