A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)

An Investigation of the Effects of Riluzole in Patients With Post-Traumatic Stress Disorder (PTSD)

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Drug: Riluzole

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • Clinical Neuroscience Division, National Center for PTSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Riluzole; Riluzole 50 mg orally twice per day	Drug: Riluzole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician Administered PTSD Scale (CAPS)	The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	12 weeks
Post-Traumatic Stress Disorder Checklist (PCL)	12 weeks
Clinical Global Impressions Scale	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for PTSD
• Investigators: Principal Investigator: Chadi Abdallah, MD, National Center for PTSD / Yale University

Publications and helpful links

Helpful Links

• National Center for PTSD

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neuroprotective Agents; Protective Agents; Anticonvulsants; Riluzole
• Other Study ID Numbers: 1308012549