Posttraumatic Stress DisorderEarly Phase 1NCT04630444
Riluzole Effects on Hippocampus Biomarkers
A Early Phase 1 study testing Riluzole in people with Posttraumatic Stress Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Riluzole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2017to 16 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18-65.
- Right handed
- Able to provide written informed consent.
- Meets DSM-5 criteria for PTSD (current month and past 3 months).
- If already receiving psychiatric intervention(s), must be on a stable regimen.
- Has normal physical examination, laboratory test results, and electrocardiogram results at pre-treatment visit.
Who cannot join
- Unwillingness or inability to provide written informed consent.
- Unable to swallow pills.
- Unable to tolerate blood draws.
- Currently enrolled in another intervention study.
- Imminent risk for self-harm (assessed by a licensed clinician)
- Active psychotic symptoms.
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- Current panic disorder.
- Lifetime history of schizophrenia spectrum disorder, bipolar disorder, obsessive compulsive disorder, anorexia nervosa, seizure disorder, or neurologic disorder.
- Urine toxicology positive for drug(s) of abuse.
- Evidence of any clinically significant medical disease.
- Women who test positive for ß-HCG, self-report as pregnant, or are nursing.
- Substance or alcohol abuse within 3 months of Visit 1. Substance or alcohol dependence within 6 months of Visit 1.
- Excessive caffeine use, defined as regular consumption of >700mg caffeine per day.
- Treatment with an antipsychotic, valproate, other anticonvulsant, reversible MAOI within 4 weeks of Visit 1. Other excluded medications will be those with (1) known glutamatergic effects, (2) previous MRS evidence of effects on brain glutamate, (3) potential effects on riluzole levels or (4) risk of neutropenia - used within 4 weeks of the first study visit.
- Previous exposure to riluzole or ketamine.
- Treatment with any investigational medicine within 30 days of Visit 1.
- Treatment with electroconvulsive therapy (ECT) within 3 months of Visit 1.
- Uncorrected thyroid disease.
- Any screening laboratory assay that is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (AST, ALT, alkaline phosphatase), which must be within 1.5 times the upper limit of normal.
- Any contraindications to having an MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS.
- Conditions
- Posttraumatic Stress Disorder
- 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
30 PTSD patients with riluzole 100 mg daily (50 mg bid).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 30 PTSD patients receiving riluzole 100 mg daily (50 mg bid). Receives: Drug: Riluzole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the clinical efficacy of riluzole in PTSD
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD total symptoms (CAPS total score)
Measured: weeks 1-8
Assessing the clinical efficacy of riluzole in PTSD
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD intrusion symptoms (CAPS intrusion subscale)
Measured: weeks 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start16 Mar 2017
- Primary completion16 Mar 2019
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Isabelle Rosso, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630444
- Sponsor's protocol ID
- 2016P002687
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2017
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
- ClinicalTrials.gov ID
- NCT04630444
- Acronym / sponsor ID
- 2016P002687
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 16 Mar 2019 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Riluzole30 PTSD patients receiving riluzole 100 mg daily (50 mg bid). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female age 18-65.
- Right handed
- Able to provide written informed consent.
- Meets DSM-5 criteria for PTSD (current month and past 3 months).
- If already receiving psychiatric intervention(s), must be on a stable regimen.
Key exclusion criteria (20 listed)
- Unwillingness or inability to provide written informed consent.
- Unable to swallow pills.
- Unable to tolerate blood draws.
- Currently enrolled in another intervention study.
- Imminent risk for self-harm (assessed by a licensed clinician)
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 |
|---|---|---|
| Riluzole30 PTSD patients with riluzole 100 mg daily (50 mg bid). | Drug | Intervention Group |
Primary outcome
Assessing the clinical efficacy of riluzole in PTSD
Time frame: weeks 1-8
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD total symptoms (CAPS total score)
Assessing the clinical efficacy of riluzole in PTSD
Time frame: weeks 1-8
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD intrusion symptoms (CAPS intrusion subscale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Riluzole in people with Posttraumatic Stress Disorder, run by Mclean Hospital 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 20 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 16 Nov 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing the clinical efficacy of riluzole in PTSD (time frame: weeks 1-8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.