Status:
NOT_YET_RECRUITING
Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans
Lead Sponsor:
San Diego Veterans Healthcare System
Collaborating Sponsors:
United States Department of Defense
Pop Test Oncology LLC
Conditions:
PTSD - Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 infor...
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...
Eligibility Criteria
Inclusion
- 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 kidney function tests within acceptable limits
- Willing to comply with all study procedures including taking oral medication, the study schedule and be available for the duration of the study Biological females, if able to conceive, must agree to use 2 forms of non-hormonal, medically acceptable contraception.
Exclusion
- Severe alcohol or substance use disorders by DSM-5 criteria in past 3 months or positive urine test for substances other than cannabis
- History or diagnosis of neurodegenerative disorders, psychotic disorders or bipolar disorder. Current treatment with antipsychotic medication for mental health
- History of suicide attempts and/or current suicidal ideation with plan or intent
- Currently using psychotropic medication (except SSRI/SNRI) or other drugs or agents which might interact with study drug. Currently taking SSRI/SNRI antidepressants for less than 30 days. Benzodiazepines or sleep agents (e.g. eszopiclone; zolpidem) are excluded; exception: trazodone 25-50 mg qhs prn for sleep or prazosin for nightmares
- Be pregnant or nursing
- HRT dose not stable for a minimum of 3 months
- Evidence of a serious, chronic medical condition that would increase the risk of an adverse outcome or history of any serious metabolic or other disease known to affect the CNS
- Have evidence of untreated or unstable medical illness including cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+/AIDS infection
- Serious cognitive impairment likely to interfere with ability to meaningfully participate
- Past brain injury/head trauma with minor loss of consciousness and current symptoms or significant loss of consciousness
- Current signs of violence or aggression
- A history of adrenal insufficiency or a plasma cortisol level ≤ 5 mcg/dl at screening
- Receiving non-pharmacotherapy treatments or procedures for where precautions exist for taking with PT150 and/or those that might interfere with the study
- Contraindication(s) to take PT150 such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity to study drug or similar compounds
- Participation in a pharmaceutical trial or use of investigational drugs within 1 month of screening
- Hearing loss that would interfere with the extinction recall measures
- Any other illness, condition, or use of medications which in the opinion of the PI and/or study investigator would preclude safe and/or successful completion of the study
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07187011
Start Date
April 1 2026
End Date
May 1 2029
Last Update
December 23 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jennifer Moreno Department of VA Medical Center
San Diego, California, United States, 92161
2
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030