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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02019940
• Collaborator: National Center for PTSD (U.S. Fed)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Drug: Riluzole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Investigation of the Effects of Riluzole in Patients With Post-Traumatic Stress Disorder (PTSD)
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Clinician Administered PTSD Scale (CAPS) [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 Outcome Measures

1. Post-Traumatic Stress Disorder Checklist (PCL) [12 weeks]

2. Clinical Global Impressions Scale [12 weeks]

3. Montgomery-Asberg Depression Rating Scale (MADRS) [12 weeks]

Other Outcome Measures

1. Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Neuroscience Division, National Center for PTSD	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University
• National Center for PTSD

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2018

More Information

Additional Information:

• National Center for PTSD

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02019940
• Other Study ID Numbers: 1308012549
• First Posted: Dec 24, 2013
• Last Update Posted: Apr 1, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Riluzole

Study Results

Participant Flow

Arm/Group Title	Riluzole Open Label
Arm/Group Description	Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Period Title: Overall Study
STARTED	18
COMPLETED	8
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Riluzole Open Label
Arm/Group Description	Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Overall Participants	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.7 (11.5)
Sex: Female, Male (Count of Participants)
Female	2 22.2%
Male	7 77.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 11.1%
Not Hispanic or Latino	8 88.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 22.2%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	7 77.8%

Outcome Measures

1. Primary Outcome

Title	Change in Clinician Administered PTSD Scale (CAPS)
Description	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.
Time Frame	Change from baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis.

Arm/Group Title	Riluzole Open Label
Arm/Group Description	Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	-20.67 (21.16)

2. Secondary Outcome

Title	Post-Traumatic Stress Disorder Checklist (PCL)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Clinical Global Impressions Scale
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
Arm/Group Title	Riluzole Open Label
Arm/Group Description	Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks
All Cause Mortality
	Riluzole Open Label
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Serious Adverse Events
	Riluzole Open Label
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Riluzole Open Label
	Affected / at Risk (%)	# Events
Total	7/9 (77.8%)
General disorders
Abdominal Pain	1/9 (11.1%)
Dry mouth	2/9 (22.2%)
Altered Taste Sensation	1/9 (11.1%)
Light headedness	2/9 (22.2%)
Headache	2/9 (22.2%)
Rhinitis, congestion, sinus pressure, postnasal drip	1/9 (11.1%)
bruxism	1/9 (11.1%)
fatigue	3/9 (33.3%)
chest pain	3/9 (33.3%)
dry cough	1/9 (11.1%)
urinary urgency	1/9 (11.1%)
edema	2/9 (22.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.