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

NCT07187011 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: H250195HT94252510832
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 inform the design of future studies.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

glucocorticoid; cortisol; trauma; veteran; PT150

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 (CAPS)

  The CAPS is the gold standard assessment of PTSD, providing a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score. This manualized clinician-assessed interview contains 30 items.

  approximately 4 weeks

Secondary Outcomes (3)

• Side Effects - Frequency, Intensity, Burden of Side Effects (FIBSER)

  1, 2, 4, 12 weeks post treatment initiation

• Alcohol Drinking - The Time Line Follow Back (TLFB)

  1, 2, 4 and 12 weeks after treatment initiation

• PTSD Symptoms - follow up

  12 weeks post treatment initiation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

PT150

EXPERIMENTAL

150-900 mg study drug dose titrated over 7 days

Drug: PT150

Interventions

PT150 DRUG

Glucorticoid antagonist 900 mg

PT150

Placebo DRUG

900 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego Veterans Healthcare System: lead
• United States Department of Defense: collaborator
• Pop Test Oncology LLC: collaborator

Study Sites (2)

Jennifer Moreno Department of VA Medical Center

San Diego, California, 92161, United States

Location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Combat Disorders; Wounds and Injuries

Interventions

(11R,13S,17S)-11-(1,3-benzodioxol-5-yl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta(a)phenanthren-3-one

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Victoria Risbrough, PhD

  San Diego VA Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Castillo, BS

CONTACT

858-552-8585; giovanni.castillo@va.gov

Erin Natale, MS

CONTACT

858-552-8585; giovanni.castillo@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VA Research Career Scientist/Health Science Research Specialist/Professor of Psychiatry

Model Details: Intervention model: The investigators propose a two-site parallel group, randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of PT 150-900 mg daily for 14 days for PTSD symptoms in Veterans.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be provided 1 year after study completion.
• Access Criteria: NDA-approved research investigators will be able to access the data.

Locations

US (2)