PTSDPhase 1NCT02019940

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

A Phase 1 study testing Riluzole in people with PTSD, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: PTSD
What is being tested?: Riluzole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Jan 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 10Show fewer

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;

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

Conditions: PTSD
Being tested: Riluzole
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RiluzoleDrug

Study groups in NCT02019940
Study group	Role	What they receive
Riluzole	Experimental	Riluzole 50 mg orally twice per day Receives: Drug: Riluzole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline to 12 weeks

Secondary outcomes (3)

Post-Traumatic Stress Disorder Checklist (PCL)
Measured: 12 weeks
Clinical Global Impressions Scale
Measured: 12 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2020

First posted24 Dec 2013 (estimated)
Study startJan 2014
Primary completionJan 2020
Study completionJan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02019940
Sponsor's protocol ID: 1308012549
Status last verified: Mar 2020
First submitted: 18 Dec 2013
Last updated: 1 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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NightWare and Cardiovascular Health in Women With PTSD
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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
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The Effects of Orexin Antagonism on Fear Extinction in PTSD
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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigation of the Effects of Riluzole in Patients With Post-Traumatic Stress Disorder (PTSD)
ClinicalTrials.gov ID: NCT02019940
Acronym / sponsor ID: 1308012549
Conditions: PTSD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Center for PTSD
Study start: Jan 2014
Primary completion: Jan 2020 (actual)
Study completion: Jan 2020 (actual)
First posted: 24 Dec 2013 (estimated)
Results: Posted 1 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Riluzole	Experimental	Drug: RiluzoleRiluzole 50 mg orally twice per day

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Riluzole	Drug	Riluzole

Primary outcome

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.

3 secondary outcomes

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

Results and safety

Results posted to the registry on 1 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Riluzole Open Label	18	8

Primary outcome: Change in Clinician Administered PTSD Scale (CAPS)

Time frame: Change from baseline to 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Riluzole Open Label n = 9
Value	-20.67 (21.16)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Riluzole Open Label	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
National Center for PTSDLink provided by the sponsor.

Related trials for PTSD

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chadi Abdallah, MD principal investigator

National Center for PTSD / Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Riluzole in people with PTSD, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinician Administered PTSD Scale (CAPS) (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02019940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.