Clinical trial NCT02019940: A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)
Official title: An Investigation of the Effects of Riluzole in Patients With Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PTSD
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for PTSD
First posted: 2013-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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;

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Checklist (PCL)
timeFrame: 12 weeks
measure: Clinical Global Impressions Scale
timeFrame: 12 weeks
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 12 weeks
Other outcomes:
measure: Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)
timeFrame: 12 weeks
Locations:
city: West Haven
country: United States
facility: Clinical Neuroscience Division, National Center for PTSD
state: Connecticut
Study officials:
affiliation: National Center for PTSD / Yale University
name: Chadi Abdallah, MD
role: PRINCIPAL_INVESTIGATOR
References: