Phase 2a Trial: Efficacy and Safety of PT150 in the Treatment of US Veterans With Posttraumatic Stress Disorder (PTSD)
San Diego Veterans Healthcare System
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.
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 d…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provide signed and dated informed consent form * Be a military service member or Veteran * Male or female, 18-65 years of age * Meet DSM-5 criteria for PTSD ≥ 3 months duration as determined by CAPS-5 * Normal vitals and a baseline EKG with clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias * Self-reported medical history and brief physical examination with no clinically significant contraindications for study participation * Blood laboratory test results for routine hematology, chemistries, liver and kidne…
Interventions
- DrugPT150
Glucorticoid antagonist 900 mg
- DrugPlacebo
900 mg
Locations (2)
- Jennifer Moreno Department of VA Medical CenterSan Diego, California
- Michael E DeBakey VA Medical CenterHouston, Texas