NCT07187011

Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans

Phase 2a Trial: Efficacy and Safety of PT150 in the Treatment of US Veterans With Posttraumatic Stress Disorder (PTSD)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: San Diego Veterans Healthcare System · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the drug PT150, which blocks glucocorticoid receptor (GR) signaling, for treatment of PTSD in Veterans, and establish a safety and efficacy profile that will inform the design of future studies.

Detailed description

This is a dual-site, proof-of-concept, parallel arm, double-blind placebo control study of a 14-day single daily dose of PT150/placebo in 100 Veterans with PTSD. Each site will enroll 60 Veterans with PTSD to ensure 100 study completers. Preclinical studies of PT150 and similar types of glucocorticoid antagonists have shown that they block stress responses in both acute and chronic models of stress response. PT150 has been tested previously in healthy control populations and in populations with depression, with it being found to be well tolerated and safe. Drug interaction results suggest it does not interact with alcohol or serotonin reuptake inhibitors, again supporting its safety and making it a candidate for further development. The goal of this Phase2a study is to tests its efficacy to reduce PTSD symptoms, as well as other biomarkers associated with PTSD. Participants first will undergo screening procedures, including a medical exam, clinical interview, self-report questionnaires, and blood draw. If eligible, they will be randomized to either PT150 or placebo. The PT150 dose will be titrated from 150-600mg over days 1-7, with the max dose of 900mg/day given the remaining 7 day timeframe. The same procedures will be repeated before, during and after taking the study drug or placebo for fourteen days. The key outcome measures will be obtained at baseline, day 28, and day 84.

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	PT150	Glucorticoid antagonist 900 mg
DRUG	Placebo	900 mg

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-01
• Completion: 2029-05-01
• First posted: 2025-09-22
• Last updated: 2025-12-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study