Riluzole Effects on Hippocampus Biomarkers

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: Riluzole

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Mclean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female age 18-65.
2. Right handed
3. Able to provide written informed consent.
4. Meets DSM-5 criteria for PTSD (current month and past 3 months).
5. If already receiving psychiatric intervention(s), must be on a stable regimen.
6. Has normal physical examination, laboratory test results, and electrocardiogram results at pre-treatment visit.

Exclusion Criteria:

1. Unwillingness or inability to provide written informed consent.
2. Unable to swallow pills.
3. Unable to tolerate blood draws.
4. Currently enrolled in another intervention study.
5. Imminent risk for self-harm (assessed by a licensed clinician)
6. Active psychotic symptoms.
7. Current panic disorder.
8. Lifetime history of schizophrenia spectrum disorder, bipolar disorder, obsessive compulsive disorder, anorexia nervosa, seizure disorder, or neurologic disorder.
9. Urine toxicology positive for drug(s) of abuse.
10. Evidence of any clinically significant medical disease.
11. Women who test positive for ß-HCG, self-report as pregnant, or are nursing.
12. Substance or alcohol abuse within 3 months of Visit 1. Substance or alcohol dependence within 6 months of Visit 1.
13. Excessive caffeine use, defined as regular consumption of >700mg caffeine per day.
14. 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.
15. Previous exposure to riluzole or ketamine.
16. Treatment with any investigational medicine within 30 days of Visit 1.
17. Treatment with electroconvulsive therapy (ECT) within 3 months of Visit 1.
18. Uncorrected thyroid disease.
19. 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.
20. Any contraindications to having an MRI scan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; 30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).	Drug: Riluzole; 30 PTSD patients with riluzole 100 mg daily (50 mg bid).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	weeks 1-8

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: Brain & Behavior Research Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2017
• Primary Completion (ACTUAL): March 16, 2019
• Study Completion (ACTUAL): March 16, 2019

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (ACTUAL): November 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neuroprotective Agents; Protective Agents; Anticonvulsants; Riluzole
• Other Study ID Numbers: 2016P002687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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