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Riluzole Effects on Hippocampus Biomarkers

NCT ID: NCT04630444

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2019-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention Group

30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).

Group Type EXPERIMENTAL

Riluzole

Intervention Type DRUG

30 PTSD patients with riluzole 100 mg daily (50 mg bid).

Interventions

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Riluzole

30 PTSD patients with riluzole 100 mg daily (50 mg bid).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain & Behavior Research Foundation

OTHER

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Rosso

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2016P002687

Identifier Type: -

Identifier Source: org_study_id