Riluzole Effects on Hippocampus Biomarkers

Posttraumatic Stress Disorder Clinical Trial

Official title:

An Investigational Study of Riluzole Effects on Hippocampus Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630444
• Other study ID #: 2016P002687
• Status: Completed
• Phase: Early Phase 1
• Start date: March 16, 2017
• Est. completion date: March 16, 2019

Study information

• Verified date: November 2020
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 16, 2019
• Est. primary completion date: March 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• Riluzole
30 PTSD patients with riluzole 100 mg daily (50 mg bid).

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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