PTSD - Post Traumatic Stress DisorderPhase 2NCT07187011
Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans
A Phase 2 study testing PT150 in people with PTSD - Post Traumatic Stress Disorder, run by San Diego Veterans Healthcare System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- PT150
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 1 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Jennifer Moreno Department of VA Medical Center
San Diego, California, 92161
About this study
Official title: Phase 2a Trial: Efficacy and Safety of PT150 in the Treatment of US Veterans With Posttraumatic Stress Disorder (PTSD)
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.
Read the 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
- Being tested
- PT150, Placebo
- Keywords
- glucocorticoid, cortisol, trauma, veteran, PT150
- Medical subject headings
- Combat Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT150Drug
Glucorticoid antagonist 900 mg
PlaceboDrug
900 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| PT150 | Experimental | 150-900 mg study drug dose titrated over 7 days Receives: Drug: PT150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 4 weeks
Secondary outcomes (3)
Side Effects - Frequency, Intensity, Burden of Side Effects (FIBSER)
The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.
Measured: 1, 2, 4, 12 weeks post treatment initiation
Alcohol Drinking - The Time Line Follow Back (TLFB)
The Time Line Follow Back (TLFB) is designed for collecting self-reported, retrospective estimates of AOD use and is extensively used to assess daily AOD use in research and practice
Measured: 1, 2, 4 and 12 weeks after treatment initiation
PTSD Symptoms - follow up
Clinician Administered PTSD Scale for DSM-5 (CAPS) will be administered at 12 weeks post treatment initiation to estimate longevity of effects of PT150 on PTSD symptoms.
Measured: 12 weeks post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, Pop Test Oncology LLC
- Responsible party
- Principal investigator, Victoria Risbrough, San Diego Veterans Healthcare System
- Investigators
- Victoria Risbrough, PhD, Principal investigator, San Diego VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187011
- Sponsor's protocol ID
- H250195
- Other IDs
- HT94252510832
- Status last verified
- Dec 2025
- First submitted
- 15 Sep 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan on sharing the de-identified data (self report, clinician assessments, laboratory measures) with qualified investigators through the National Institute of Mental Health Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Trial: Efficacy and Safety of PT150 in the Treatment of US Veterans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07187011
- Acronym / sponsor ID
- H250195
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- glucocorticoid, cortisol, trauma, veteran, PT150
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Collaborators
- United States Department of Defense, Pop Test Oncology LLC
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| PT150 | Experimental | Drug: PT150150-900 mg study drug dose titrated over 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT150Glucorticoid antagonist 900 mg | Drug | PT150 |
| Placebo900 mg | Drug | Placebo |
Primary outcome
PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 (CAPS)
Time frame: 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.
3 secondary outcomes
Side Effects - Frequency, Intensity, Burden of Side Effects (FIBSER)
Time frame: 1, 2, 4, 12 weeks post treatment initiation
Alcohol Drinking - The Time Line Follow Back (TLFB)
Time frame: 1, 2, 4 and 12 weeks after treatment initiation
PTSD Symptoms - follow up
Time frame: 12 weeks post treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. We plan on sharing the de-identified data (self report, clinician assessments, laboratory measures) with qualified investigators through the National Institute of Mental Health Data Archive (NDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Risbrough, PhD principal investigator
San Diego VA Healthcare System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PT150 in people with PTSD - Post Traumatic Stress Disorder, run by San Diego Veterans Healthcare System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Castillo, BS (858-552-8585 ext. 5970, giovanni.castillo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 (CAPS) (time frame: approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.