PT150 for PTSD

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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+