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

NCT02019940 | Completed Phase 1 Results

• 1 other identifier: 1308012549
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-Traumatic Stress Disorder Checklist (PCL)

  12 weeks

• Clinical Global Impressions Scale

  12 weeks

• Montgomery-Asberg Depression Rating Scale (MADRS)

  12 weeks

Other Outcomes (1)

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

  12 weeks

Study Arms (1)

Riluzole

EXPERIMENTAL

Riluzole 50 mg orally twice per day

Drug: Riluzole

Interventions

Riluzole DRUG

Riluzole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Yale University: lead
• National Center for PTSD: collaborator

Study Sites (1)

Clinical Neuroscience Division, National Center for PTSD

West Haven, Connecticut, 06516, United States

Location

Related Links

• National Center for PTSD

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Chadi Abdallah
• Organization: Yale School of Medicine

chadi.abdallah@yale.edu

347-987-0717

Study Officials

• Chadi Abdallah, MD

  National Center for PTSD / Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 1, 2020
• Results First Posted: April 1, 2020

Record last verified: 2020-03

Locations

US (1)