NCT04630444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2019

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

July 14, 2017

Last Update Submit

November 10, 2020

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Drug: Riluzole

Interventions

RiluzoleDRUG

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

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2017

First Posted

November 16, 2020

Study Start

March 16, 2017

Primary Completion

March 16, 2019

Study Completion

March 16, 2019

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

US(1)