A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Riluzole
Intervention MeSH terms: Riluzole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This open label study will evaluate the safety and efficacy of riluzole in patients with
      PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient,
      with a one month follow up at week 16.
    

Eligibility 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;