Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female subjects between the ages of 18-75 years;
Able to provide written informed consent;
Current Post Traumatic Stress Disorder, as determined by the Clinician Administered Scale for PTSD, or the presence of sub-threshold PTSD. Individuals with sub-threshold PTSD will be included at the discretion of the PI;
Clinician Administered PTSD Scale (CAPS) score of 23 or higher;
Be able to understand and speak English.
Subjects taking FDA-approved antidepressant medications may enter the study if they have been on a stable dose for at least 4 weeks prior to starting the study drug.

Exclusion Criteria:

Breastfeeding women and pregnant women, or women of child bearing potential who are not using a medically accepted means of contraception (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy);
Current, ongoing serious suicidal risk as assessed by evaluating investigator or by scoring 5 or more on the item-10 of the MADRS.
Unstable medical illness as determined by the investigator;
Patients with schizophrenia or schizoaffective disorders (current or past);
Substance use disorder during the 3 months prior to screening; except for Cannabis and Alcohol use Disorders.
Clinical evidence of untreated hypothyroidism;
Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level > 1.5 x ULN at initial screening, or > 5 x ULN during treatment;
Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance, as determined by the investigator during open-ended psychiatric interview;
Patients currently being treated for a respiratory disorder (including asthma or COPD);
For participants over the age of 60, evidence of dementia as determined by the St. Luis University Mental Status Exam (SLUMS; participants with total scores less than or equal to 20 will be excluded and referred to their Primary Care Physician for follow-up/dementia evaluation); Structured psychotherapy focused on treatment of PTSD is exclusionary unless the subject has had at least 8 weeks of treatment prior to starting the study medication;