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OpenTrials
Completed

NCT Number: NCT04630444

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Riluzole

Drug

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

Primary outcomes

  1. Assessing the clinical efficacy of riluzole in PTSD

    Time frame: 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

    Time frame: weeks 1-8

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

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Brain & Behavior Research Foundation

Registry information

Official study title

An Investigational Study of Riluzole Effects on Hippocampus Biomarkers

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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