PT150 for PTSD

Not yet recruiting at 1 trial location

Overseen By Erin Natale, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: San Diego Veterans Healthcare System

Must be taking: SSRI/SNRI

Must not be taking: Antipsychotics, Benzodiazepines

Disqualifiers: Substance use, Neurodegenerative, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called PT150 to determine its effectiveness in treating PTSD (post-traumatic stress disorder) in military veterans. PT150 blocks certain signals in the body linked to stress responses. The trial includes two groups: one takes PT150, and the other takes a placebo (a pill with no active ingredient) for comparison. Veterans with PTSD for at least three months, who are not dealing with severe substance abuse or certain other mental health issues, might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. If you are currently using psychotropic medications (except certain antidepressants like SSRI/SNRI) or benzodiazepines, you might need to stop. Please discuss your specific medications with the study team.

Is there any evidence suggesting that PT150 is likely to be safe for humans?

Research has shown that PT150 was safe in earlier studies. Notably, it was safe to use with alcohol, which is promising for its use in larger trials. PT150 blocks certain stress hormones, and studies have not identified any major safety issues so far.

Since this study is in Phase 2, PT150 has already undergone initial safety tests in earlier phases. It is generally well-tolerated, but this study will gather more information to confirm its safety for treating PTSD in veterans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

PT150 is unique because it offers a novel approach to treating PTSD by targeting the glucocorticoid receptor, which plays a key role in the body's stress response. Unlike standard treatments such as SSRIs like sertraline and paroxetine, which primarily focus on altering serotonin levels, PT150 aims to directly modulate the body's stress hormones. Researchers are excited about PT150 because this mechanism could potentially lead to more rapid and effective relief from PTSD symptoms, addressing a crucial need for faster-acting treatments in this field.

What evidence suggests that PT150 might be an effective treatment for PTSD?

Research suggests that PT150, a drug that blocks certain stress signals in the brain, might help treat PTSD by reducing stress responses. In this trial, some participants will receive PT150 to evaluate its effectiveness in managing PTSD symptoms. Although direct studies on PTSD are limited, PT150 has shown promise in reducing stress-related behaviors in early tests for other conditions. This suggests it could help manage PTSD symptoms by targeting stress pathways in the brain. Initial findings are encouraging, but further research is needed to confirm its effects specifically for PTSD. ^{1 2 3 4 6}

Who Is on the Research Team?

Victoria Risbrough, PhD

Principal Investigator

San Diego VA Healthcare System

Are You a Good Fit for This Trial?

This trial is for military service members or Veterans aged 18-65 with PTSD lasting at least 3 months. They must have normal vital signs, EKG, and lab tests. Women able to conceive must use two forms of contraception. Exclusions include pregnancy, severe cognitive impairment, recent substance abuse, suicidal behavior, certain medical conditions like liver impairment or untreated illnesses.

Inclusion Criteria

Provide signed and dated informed consent form

Be a military service member or Veteran

Normal vitals and a baseline EKG with clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias

Exclusion Criteria

Be pregnant or nursing

Serious cognitive impairment likely to interfere with ability to meaningfully participate

Current signs of violence or aggression

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 14-day single daily dose of 900 mg of PT150 or placebo

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with key outcome measures obtained at baseline, day 28, and day 84

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PT150

Trial Overview The study is testing PT150's effectiveness in treating PTSD by blocking glucocorticoid receptor signaling compared to a placebo. Participants will take oral medication and follow the study procedures over the course of the trial to determine safety and efficacy.

How Is the Trial Designed?

Group I: PT150 Experimental Treatment 1 Intervention

900 mg

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

San Diego Veterans Healthcare System

Lead Sponsor

Trials

38

Recruited

5,500+

Pop Test Oncology LLC

Industry Sponsor

Trials

3

Recruited

50+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10084834/

Effect of the glucocorticoid receptor antagonist PT150 on ... Although PT150 may serve as an effective treatment for reducing risk of OUD following early life stress in males, further work is needed to determine the ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT07187011

Initial Study Sesting Efficacy and Tolerability of PT150 for ... 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 ...

3. scholars.uky.edu scholars.uky.edu/en/projects/preclinical-assessment-of-pt-150-for-opioid-use-disorder-and-ptsd/

Preclinical Assessment of PT-150 for Opioid Use Disorder and ... The primary hypothesis is that PT-150 will reduce the stress-induced increase in fentanyl selfadministration. If this latter result is obtained, it will form ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07187011?term=TREATMENt

Initial Study Sesting Efficacy and Tolerability of PT150 for ... The purpose of this study is to test the drug PT150, which blocks glucocorticoid receptor (GR) signaling, for treatment of PTSD in Veterans, and ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/post-traumatic-stress-disorder

UCSD Post-Traumatic Stress Disorder Clinical Trials for 2025 The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural ...

6. firstwordpharma.com firstwordpharma.com/story/5990485

Palisades Therapeutics Announces Groundbreaking ... "PT150's demonstrated safety when combined with alcohol clears the path for larger Phase II efficacy trials and brings us significantly closer ...