Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

ClinicalTrials.gov ID: NCT02733614

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Official title

A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

Study identification

NCT ID: NCT02733614
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: Azevan Pharmaceuticals; Industry
Enrollment: 33 participants

Conditions and interventions

Conditions

PTSD

Interventions

SRX246 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2016 (Actual)
Primary completion: Oct 2020 (Actual)
Completion: Mar 31, 2021 (Actual)
Last update posted: Nov 1, 2021

2016 – 2021

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Weill Cornell Medical College	New York	New York	10065	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02733614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 1, 2021 · Synced Nov 14, 2026