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OpenTrials
Completed

NCT Number: NCT02019940

A Pilot Study 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Neuroscience Division, National Center for PTSD

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Riluzole

Drug

Primary outcomes

  1. Change in Clinician Administered PTSD Scale (CAPS)

    Time frame: Change from baseline to 12 weeks

    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.

Secondary outcomes

  1. Post-Traumatic Stress Disorder Checklist (PCL)

    Time frame: 12 weeks

  2. Clinical Global Impressions Scale

    Time frame: 12 weeks

  3. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: 12 weeks

Other outcomes

  1. Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for PTSD

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2013
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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