A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder.

Hyperarousal Memory consolidation Military trauma Pharmacotherapy Sleep quality Time since trauma

Journal

Psychiatry research
ISSN: 1872-7123
Titre abrégé: Psychiatry Res
Pays: Ireland
ID NLM: 7911385

Informations de publication

Date de publication:
Apr 2024
Historique:
received: 27 09 2023
revised: 20 01 2024
accepted: 26 01 2024
pubmed: 14 2 2024
medline: 14 2 2024
entrez: 13 2 2024
Statut: ppublish

Résumé

Sleep disturbances in posttraumatic stress disorder (PTSD) are a potential target for improving PTSD severity with pharmacotherapy. TNX-102 SL is a bedtime sublingual formulation of cyclobenzaprine with potent binding and antagonist activity at 5-HT

Identifiants

pubmed: 38350291
pii: S0165-1781(24)00049-0
doi: 10.1016/j.psychres.2024.115764
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

115764

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest MP consulted with Tonix on the preparation, creation, and presentation of the published work. SL and GMS are employees of Tonix Pharmaceuticals, Inc. (Tonix) and own stock and/or have options in the company. JE is an employee of Tonix and previously consulted on the statistical analyses in the study. BV is the primary statistician consulting for Tonix as an employee of Rho, Inc. LLD has received income as consultant from Otsuka, Lundbeck, Signant Health, and Boehringer Ingelheim and has received research funding or materials from Tonix, Alkermes, Aptinyx, Social Finance, and Westat.

Auteurs

Megan E Parmenter (ME)

Massachusetts General Hospital, Home Base Program, Charlestown, MA, United States.

Seth Lederman (S)

Tonix Pharmaceuticals, Inc., Chatham, NJ, United States.

Frank W Weathers (FW)

National Center for PTSD, Behavioral Science Division, VA Boston Healthcare System, and Department of Psychiatry, Boston University School of Medicine, Boston, MA, United States.

Lori L Davis (LL)

Research Service, Tuscaloosa Veterans Affairs Medical Center, Tuscaloosa, AL, United States; Department of Psychiatry, University of Alabama Heersink School of Medicine, Birmingham, AL, United States; Department of Psychiatry, University of Alabama College of Community Health Sciences, Tuscaloosa, AL.

Benjamin Vaughn (B)

Biostatistics, Rho, Inc., Chapel Hill, NC, United States.

Jean Engels (J)

Tonix Pharmaceuticals, Inc., Chatham, NJ, United States.

Gregory M Sullivan (GM)

Tonix Pharmaceuticals, Inc., Chatham, NJ, United States. Electronic address: greg.sullivan@tonixpharma.com.

Classifications MeSH