Evidence map›Paper›PMID 33113596›Full record

Trial reportThe Journal of clinical psychiatry2020

Randomized Controlled Trial of Riluzole Augmentation for Posttraumatic Stress Disorder: Efficacy of a Glutamatergic Modulator for Antidepressant-Resistant Symptoms.

Patricia T Spangler, James C West, Catherine L Dempsey, Kyle Possemato, Danielle Bartolanzo, Pablo Aliaga, Carlos Zarate, Meena Vythilingam, David M Benedek

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02155829 (Riluzole for PTSD), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02155829 phase1 / phase2completednot on this map

Riluzole for PTSD: Efficacy of a Glutamatergic Modulator as Augmentation Treatment for Posttraumatic Stress Disorder

TypeinterventionalSponsorUniformed Services University of the Health SciencesRan2013 to 2017Enrolled75ConditionsPTSDArmsRiluzole, Placebo (for Riluzole)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Patricia T SpanglerPatricia Spangler, PhD, Department of Psychiatry, Uniformed Services University, 4301 Jones Bridge Rd, Bethesda, MD 20816. patricia.spangler.ctr@usuhs.edu.
James C WestDepartment of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.
Catherine L DempseyCenter for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.
Kyle PossematoVeterans Administration Center for Integrated Healthcare, Syracuse, New York, USA.
Danielle BartolanzoCenter for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.
Pablo AliagaCenter for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.
Carlos ZarateExperimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, Maryland, USA.
Meena VythilingamSenior Mental Health Advisor, Office of the Assistant Secretary for Health, Washington, DC, USA.
David M BenedekDepartment of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.
Marymount University · USUniformed Services University of the Health Sciences · USHenry M. Jackson Foundation · USOffice of the Assistant Secretary for Health · USSyracuse VA Medical Center · US

Funding

Target validation of novel therapeutic agents in mood disordersZIAMH002927 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2010 to 2025
$37.1M
Intramural NIH HHS ZIA MH002927
6 · The paper itself

Abstract

objectiveCurrent pharmacologic treatments for posttraumatic stress disorder (PTSD) have shown limited efficacy, prompting a call to investigate new classes of medications. The current study investigated the efficacy of glutamate modulation with riluzole augmentation for combat-related PTSD symptoms resistant to treatment with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

methodsA randomized, double-blind, placebo-controlled, parallel trial was conducted at Walter Reed National Military Medical Center and Syracuse VA Medical Center between December 2013 and November 2017. Veterans and active duty service members with combat-related PTSD (per the Clinician Administered PTSD Scale [CAPS]) who were not responsive to SSRI or SNRI pharmacotherapy were randomized to 8-week augmentation with a starting dose of 100 mg/d of riluzole (n = 36) or placebo (n = 38) and assessed weekly for PTSD symptoms, anxiety, depression, disability, and side effects.

resultsIntent-to-treat analyses (N = 74) of the primary outcome (CAPS for DSM-IV) showed no significant between-group difference in change in overall PTSD symptoms (F = 0.64, P = .422), with a small effect size (d = 0.25). There was clinically significant within-group improvement in overall PTSD symptoms in both groups, with a greater mean (SD) decrease in CAPS score in the riluzole group (-21.1 [18.9]) than in the placebo group (-16.7 [17.2]). Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.

conclusionsAlthough preliminary, the exploratory findings of this study offer some evidence that riluzole augmentation of an SSRI or SNRI may selectively improve PTSD hyperarousal symptoms without changes in overall PTSD symptoms, depression, anxiety, or disability. Additional investigation of the mechanism of the efficacy of riluzole for hyperarousal symptoms is warranted.

trial registrationClinicalTrials.gov identifier: NCT02155829.

Indexed as

AdultAnxietyDepressionDouble-Blind MethodDrug SynergismDrug Therapy, CombinationExcitatory Amino Acid AntagonistsFemaleHumansMaleMiddle AgedMilitary PersonnelRiluzoleSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake InhibitorsStress Disorders, Post-TraumaticExcitatory Amino Acid AntagonistsRiluzoleSelective Serotonin Reuptake InhibitorsSerotonin and Noradrenaline Reuptake Inhibitors

Identifiers

PMID33113596
PMCPMC7673650
OpenAlexW3096865374

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.