Vortioxetine for Posttraumatic Stress Disorder
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.
|Post-Traumatic Stress Disorder||Drug: Placebo Drug: Vortioxetine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy of Vortioxetine for Posttraumatic Stress Disorder|
- An improved PTSD scale score [ Time Frame: From Baseline to Week 12 ]Mean changes in the Clinician-Administered PTSD Scale (CAPS)
- A 50% improved overall response rate on a PTSD scaled score. [ Time Frame: From Baseline to Week 12 ]50% improvement from baseline in the Clinically-Administered PTSD Scale (CAPS).
- Reduction in depressive symptoms in PTSD [ Time Frame: From Baseline to Week 12 ]Determined by mean changes by the Montgomery-Asberg Depression Rating Scale (MADRS).
- 50% improvement in CGI-Score [ Time Frame: From Baseline to Week 12 ]50% improvement in Clinical Global Impression of Improvement (CGI-I) score of 1 or 2.
|Study Start Date:||December 2016|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo pill once daily for 12 weeks of active treatment.
Active Comparator: Vortioxetine
Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02637895
|Contact: Gabriela Vargas, B.Semail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Gabriela Vargas, B.S 305-243-2708 firstname.lastname@example.org|
|Principal Investigator: Philip Harvey, PhD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Jaclyn W Gray 404-778-6663 email@example.com|
|Principal Investigator: Boadie W Dunlop, M.D|
|Principal Investigator:||Philip Harvey, PhD||University of Miami|