Phase 3 PTSD Trial, Recruiting NCT06333990 Sponsor: Foundation for Advancing Veterans' Health Research Condition: PTSD
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Phase 3 PTSD Trial, Recruiting

NCT06333990
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Veterans (male or female) who are seeking treatment for mild traumatic brain injury (mild TBI) and are between 18 and 65 years old
  • People who have been diagnosed with mild TBI and are experiencing ongoing symptoms after the injury, with at least 6 months having passed since the injury occurred
  • People who have been on at least three medications that affect the brain or mental health (such as psychiatric medications) for more than one month, with no dose changes in that time
  • People who have a certain level of post-traumatic stress symptoms, as measured by a standard checklist used by clinicians

Who may not be able to join:

  • People who have had a moderate or severe traumatic brain injury, or who have been diagnosed with a condition involving significant memory or thinking decline (such as dementia)
  • People who meet the clinical criteria for schizophrenia, bipolar disorder, or schizoaffective disorder, or who have been hospitalised for a psychiatric condition currently or within the past 6 months
  • People who are currently taking antipsychotic medications or certain other prohibited medications within the past month
  • People who have a known intolerance to the medication quetiapine, or who have unstable heart, lung, liver, kidney, blood, or hormonal conditions, diabetes, severe sleep apnoea, or a seizure disorder
  • People who have a substance use disorder serious enough to have required medication treatment, medical detox, or hospitalisation within the 6 months before screening
  • People who have had certain serious levels of suicidal thoughts or plans, or thoughts of harming others, within the past 3 months, or who have made a suicide attempt or shown suicidal behaviour within the past 6 months
  • People who have a known history of irregular heart rhythms or a specific abnormal heart reading on an ECG (confirm with trial site)
  • Women who are pregnant or breastfeeding, or women of childbearing potential who are not using a reliable form of contraception

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 210-617-5300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Foundation for Advancing Veterans' Health Research
Registry
ClinicalTrials.gov
Start date
9 July 2024
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Neurobehavioral Symptom Inventory; World Health Organization Disability Assessment Scale; World Health Organization Quality of Life BREF

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov