Vortioxetine for Posttraumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo; Vortioxetine
Intervention description: Placebo pill matching Vortioxetine.; Immediate Release 10 mg. Vortioxetine Pill
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PTSD,; trauma; stress disorder; post-traumatic stress disorder; anxiety disorder

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.
    

Eligibility criteria:

        Inclusion

          1. Males and Females between the ages of 18 and 65

          2. Fulfills Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
             criteria for primary diagnosis of PTSD.

          3. Able to give consent

          4. Willingness to sign the treatment contract

          5. A negative urine toxicology

          6. For females of reproductive age, use of an effective birth control method* for the
             duration of the study or abstinence.

          7. Duration of illness of PTSD for at least 3 months

          8. An initial score at Screening, and Visit 3 (randomization) of ≥ 50 on the Clinician
             Administered PTSD Scale (CAPS) for PTSD Studies

        Exclusion

          1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder, dementia,
             bipolar disorder.

          2. Subject is currently participating in another clinical trial in which s/he is or will
             be exposed to an investigational or non-investigational drug or device, or has done so
             within the preceding month.

          3. Current evidence or history of significant unstable medical illness or organic brain
             impairment, including stroke, Central Nervous System (CNS) tumor, demyelinating
             disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would
             likely interfere with the action, absorption, distribution, metabolism, or excretion
             of Vortioxetine. History of moderate or more severe Traumatic Brain Injury (TBI) will
             also be exclusionary.

          4. Patients who in the investigator's judgment pose a current suicidal or homicidal risk

          5. DSM-5 substance abuse or dependence within the past 90 days. Subject has a positive
             urine toxicology test for illegal substances.

          6. Diagnosis of anorexia nervosa, bulimia, or Obsessive Compulsive Disorder (OCD) in the
             past year.

          7. Subject has a documented history of hepato-biliary disease including a history of, or
             positive laboratory results for hepatitis (hepatitis B surface antigen and/or
             hepatitis C antibody), and clinically significant hepatic enzyme elevation, including
             any one of the following enzymes greater than 3 times the upper limit of normal (ULN)
             value (Alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline
             phosphatase( ALP)), or total or direct bilirubin > 1.5 x ULN, unless consistent with
             presumed or diagnosed Gilbert's disease

          8. Subject has taken systemic corticosteroids within 2 weeks of the Randomization Visit

          9. Treatment with any other psychoactive medication within 2 weeks of Visit 1, including
             all antidepressants, psychoactive herbal or nutritional treatment (St Johns
             Wort,S-Adenosyl methionine(SAM-e)), lithium, other mood stabilizers, oral
             antipsychotics, depot antipsychotics within 12 weeks, beta blockers, thioridazine,
             pimozide, opiates, anxiolytics, and sedatives (with the exception of zolpidem,
             eszopiclone, and zaleplon). Also any treatment with any medication that the PI judges
             not acceptable for this study.

         10. Pregnancy or lactation*

         11. Subjects who, in the opinion of the investigator, would be noncompliant with the visit
             schedule or study procedures (e.g. illiteracy, planned vacations, or planned
             hospitalizations during the study).

         12. Any laboratory abnormality that in the investigator's judgment is considered to be
             clinically significant

         13. Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms

         14. Current or planned litigation or other actions related to secondary gain regarding the
             traumatic event

         15. Subject has clinical evidence of, or ElectroCardiogram (ECG) results indicating any of
             the following at either screen or Randomization Visit unless repeat ECG shows that the
             parameter had returned to within normal range by the Randomization Visit:

               -  Q to T interval change (QTc)> 450 msec for men, or > 475 msec for women;

               -  any cardiac condition or ECG evidence that the investigator feels may pose a
                  potential safety concern.