A POC Clinical Trial for PTSD with a First-In-Class Vasopressin 1a Receptor Antagonist

Abstract

A sample of 33 patients were randomized to the two-arm crossover treatment vs. placebo trial. Randomization was balanced by sex and comorbid major depression. The primary outcome, CAPS-5 Severity, decreased significantly over the course of the study. Although the primary mixed effects model did not show significant treatment differences, the study was underpowered and only about half of the participants completed both crossover phases due to documented issues in recruiting. Examination of effect sizes adjusted by covariates suggested superiority for SRX246, a first-in-class vasopressin 1a receptor antagonist, with an effect about 30% higher than placebo. These preliminary findings suggest SRX246 may be an effective treatment for PTSD. If confirmed through additional clinical studies, SRX246 would represent a breakthrough in pharmacotherapy for PTSD, where effective treatments are needed for warfighters, veterans, and civilians.

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Document Details

Document Type
Technical Report
Publication Date
Mar 01, 2021
Accession Number
AD1148554

Entities

People

  • JoAnn Difede
  • Neal G. Simon

Tags

DTIC Thesaurus Topics

  • Analysis Of Variance
  • Biomedical Research
  • Clinical Trials
  • Data Analysis
  • Data Management
  • Data Science
  • Databases
  • Depression
  • Descriptive Analytics
  • Health Services
  • Hospitals
  • Humanities
  • Information Science
  • Internet
  • Medical Personnel
  • Military Personnel
  • Monitoring
  • New York
  • Personnel Management
  • Physicians
  • Professional Development
  • Quality Of Life
  • Statistical Analysis

Fields of Study

  • Psychology

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