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

{ "Study of PT150 for PTSD in Veterans", "This study is testing a drug called PT150, a glucocorticoid antagonist, to see if it can help veterans with Post-Traumatic Stress Disorder (PTSD). PT150 works by blocking certain stress responses in the body. You would receive either PT150 or a placebo (an inactive substance) for 14 days. Researchers will measure your PTSD symptoms using a special questionnaire (Clinician Administered PTSD Scale for DSM-5 or CAPS) after about 4 weeks to see if PT150 is effective. This study is looking for 120 military service members or veterans between 18 and 65 years old who have been diagnosed with PTSD for at least three months. The current recruitment status is unclear.", "design": "This is a double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving PT150 or the placebo. It aims to enroll 120 veterans.", "commitments": "You would undergo screening, including a medical exam, interview, questionnaires, and blood draw. If eligible, you would take the study drug or placebo for 14 days, with procedures repeated before, during, and after this period.", "compensation": "Not stated in the trial record.", "follow_up": "Your PTSD symptoms will be measured approximately 4 weeks after the study begins.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

PHASE2Ages 18–65InterventionalTreatment

San Diego Veterans Healthcare System

~120 participants

Updated 2025-12-23 on ClinicalTrials.gov

What's tested:PT150Placebo

At a glance

Recruiting sites

0 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over approximately 4 weeks

Conditions

PTSD - Post Traumatic Stress Disorder

Where it's being run

2 sites across 2 states

California1

Texas1

Study leadership

Victoria Risbrough, PhD · PRINCIPAL_INVESTIGATOR · San Diego VA Healthcare System

Who to contact

Giovanni Castillo, BS

[email protected]

858-552-8585 · ext. 5970

Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 (CAPS)approximately 4 weeks
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.

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