Back to resultsRiluzole Effects on Hippocampus Biomarkers
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Riluzole
Sponsored by
About this trial
This is an interventional basic science trial for Posttraumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04630444
First Posted
July 14, 2017
Last Updated
November 10, 2020
Sponsor
Mclean Hospital
Collaborators
Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04630444
Brief Title
Riluzole Effects on Hippocampus Biomarkers
Official Title
An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
March 16, 2019 (Actual)
Study Completion Date
March 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Brain & Behavior Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).
Intervention Type
Drug
Intervention Name(s)
Riluzole
Intervention Description
30 PTSD patients with riluzole 100 mg daily (50 mg bid).
Primary Outcome Measure Information:
Title
Assessing the clinical efficacy of riluzole in PTSD
Description
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD total symptoms (CAPS total score)
Time Frame
weeks 1-8
Title
Assessing the clinical efficacy of riluzole in PTSD
Description
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD intrusion symptoms (CAPS intrusion subscale)
Time Frame
weeks 1-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Riluzole Effects on Hippocampus Biomarkers
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