Vortioxetine for Posttraumatic Stress Disorder

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.

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 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 (TBHI) 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 (ALT, AST, ALP), or total or direct bil > 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,
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:

- 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.