Evidence map›Paper›PMID 21194898›Full record

Trial reportEuropean neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology2011

A selective neurokinin-1 receptor antagonist in chronic PTSD: a randomized, double-blind, placebo-controlled, proof-of-concept trial.

Sanjay J Mathew, Meena Vythilingam, James W Murrough, Carlos A Zarate, Adriana Feder, David A Luckenbaugh, Becky Kinkead, Michael K Parides, David G Trist, Massimo S Bani and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pharmacotherapy for post traumatic stress disorder (PTSD).The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Neuropeptidergic systems in psychiatric disorders.Frontiers in endocrinology · 2025
    Review
  6. Article
  7. Article
  8. Limbic Neuropeptidergic Modulators of Emotion and Their Therapeutic Potential for Anxiety and Post-Traumatic Stress Disorder.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2021
    Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Emerging drugs for the treatment of anxiety.Expert opinion on emerging drugs · 2015
    Review
  16. Article
  17. Review
  18. Review
  19. Targeting memory processes with drugs to prevent or cure PTSD.Expert opinion on investigational drugs · 2012
    Review
  20. Review
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

13 authors at 5 institutions in 2 countries.

Sanjay J MathewMood & Anxiety Disorders Program, Department of Psychiatry, Mount Sinai School of Medicine, New York, NY, USA. sjmathew@bcm.edu
Meena Vythilingam
James W Murrough
Carlos A Zarate
Adriana Feder
David A Luckenbaugh
Becky Kinkead
Michael K Parides
David G Trist
Massimo S Bani
Paolo U Bettica
Emiliangelo M Ratti
Dennis S Charney
GlaxoSmithKline (Italy) · ITIcahn School of Medicine at Mount Sinai · USNational Institute of Mental Health · USDean College · USEmory University · 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
Projevt 5: Effects of the CRF1 receptor antagonist in patients w/PTSD: a plcebocoU19MH069056 · NIMH · EMORY UNIVERSITY · PI DAVIS, MICHAEL E · 2003 to 2013
$15.4M
NIMH NIH HHS U19 MH069056
6 · The paper itself

Abstract

The substance P-neurokinin-1 receptor (SP-NK(1)R) system has been extensively studied in experimental models of stress, fear, and reward. Elevated cerebrospinal fluid (CSF) SP levels were reported previously in combat-related PTSD. No medication specifically targeting this system has been tested in PTSD. This proof-of-concept randomized, double-blind, placebo-controlled trial evaluated the selective NK(1)R antagonist GR205171 in predominately civilian PTSD. Following a 2-week placebo lead-in, 39 outpatients with chronic PTSD and a Clinician-Administered PTSD Scale (CAPS) score ≥50 were randomized to a fixed dose of GR205171 (N=20) or placebo (N=19) for 8weeks. The primary endpoint was mean change from baseline to endpoint in the total CAPS score. Response rate (≥50% reduction in baseline CAPS) and safety/tolerability were secondary endpoints. CSF SP concentrations were measured in a subgroup of patients prior to randomization. There was significant improvement in the mean CAPS total score across all patients over time, but no significant difference was found between GR205171 and placebo. Likewise, there was no significant effect of drug on the proportion of responders [40% GR205171 versus 21% placebo (p=0.30)]. An exploratory analysis showed that GR205171 treatment was associated with significant improvement compared to placebo on the CAPS hyperarousal symptom cluster. GR205171 was well-tolerated, with no discontinuations due to adverse events. CSF SP concentrations were positively correlated with baseline CAPS severity. The selective NK(1)R antagonist GR205171 had fewer adverse effects but was not significantly superior to placebo in the short-term treatment of chronic PTSD. (ClinicalTrials.gov Identifier: NCT 00211861, NCT 00383786).

Indexed as

Neurokinin-1 Receptor AntagonistsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPiperidinesPlacebosPsychiatric Status Rating ScalesStress Disorders, Post-TraumaticSubstance PTetrazolesTime FactorsTreatment OutcomeYoung AdultNeurokinin-1 Receptor AntagonistsPiperidinesPlacebosSubstance PTetrazolesvofopitant

Identifiers

PMID21194898
PMCPMC3478767
OpenAlexW1968246586

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.