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Riluzole Effects on Hippocampus Biomarkers

Sponsor
Mclean Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04630444
Collaborator
Brain & Behavior Research Foundation (Other)
20
Enrollment
1
Location
1
Arm
24
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
Actual Study Start Date :
Mar 16, 2017
Actual Primary Completion Date :
Mar 16, 2019
Actual Study Completion Date :
Mar 16, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Assessing the clinical efficacy of riluzole in PTSD [weeks 1-8]

    Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD total symptoms (CAPS total score)

  2. Assessing the clinical efficacy of riluzole in PTSD [weeks 1-8]

    Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD intrusion symptoms (CAPS intrusion subscale)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 McLean Hospital Belmont Massachusetts United States 02478

Sponsors and Collaborators

  • Mclean Hospital
  • Brain & Behavior Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Isabelle Rosso, Associate Professor, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT04630444
Other Study ID Numbers:
  • 2016P002687
First Posted:
Nov 16, 2020
Last Update Posted:
Nov 16, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Riluzole

Study Results

No Results Posted as of Nov 16, 2020