Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans
NCT ID: NCT07187011
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2026-04-01
2029-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PT150
150-900 mg study drug dose titrated over 7 days
PT150
Glucorticoid antagonist 900 mg
Placebo
Placebo
Placebo
900 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PT150
Glucorticoid antagonist 900 mg
Placebo
900 mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
Pop Test Oncology LLC
INDUSTRY
San Diego Veterans Healthcare System
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Victoria Risbrough
VA Research Career Scientist/Health Science Research Specialist/Professor of Psychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victoria Risbrough, PhD
Role: PRINCIPAL_INVESTIGATOR
San Diego VA Healthcare System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jennifer Moreno Department of VA Medical Center
San Diego, California, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT94252510832
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H250195
Identifier Type: -
Identifier Source: org_study_id