Phase 3 PTSD Trial, Recruiting NCT06412757 Sponsor: Deakin University Condition: PTSD
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Phase 3 PTSD Trial, Recruiting

NCT06412757
Recruiting Phase 3 🇦🇺 Australian site

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:

  • People aged 18 years or older.
  • People who are fluent in English.
  • People who have been assessed as meeting the clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) according to a standard diagnostic interview.
  • People whose PTSD symptom score on a standard checklist (called the PCL-5) is 33 or higher.

Who may not be able to join:

  • People who are currently serving in the Australian Defence Force.
  • People with a history of a psychotic disorder, bipolar disorder, or dissociative identity disorder at any point in their life.
  • People who have had a moderate or severe alcohol or other substance use problem within the 3 months before screening.
  • People who are currently experiencing thoughts of suicide or harming others.
  • People who have been diagnosed with Borderline Personality Disorder (BPD).
  • People with a serious or unstable physical health condition that would make trial participation unsafe or unsuitable.
  • People who are pregnant, breastfeeding, or who are unwilling to use an acceptable form of contraception throughout their involvement in the trial up to week 16 (this applies to both men and women who could potentially conceive). Participants would also be asked not to donate eggs or sperm during the study.
  • People who have started a trauma-focused talking therapy (such as Prolonged Exposure, Cognitive Processing Therapy, or EMDR) within the 3 months before screening.
  • People who have started taking or changed the dose of any psychiatric medication within 4 weeks before screening.
  • People who would need to start a new talking therapy or change psychiatric medication doses during the study — this would be assessed case by case, and participation may need to end if this happens (confirm with trial site).
  • People with a severe acquired brain injury.
  • People whose visa status in Australia means they are not eligible for public mental health services.
  • People with any other condition that the research team believes would make completing the trial unrealistic.
  • People who are unable to understand or speak English well enough to give informed consent and complete the trial, as determined by the researcher or clinician.

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 26 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

Principal Investigator: Michael Berk, PhD, Deakin University

Phone: +61 3 9035 4749

Australian sites

University of Melbourne, Carlton, Victoria
(03) 9035 7883
Deakin University, Geelong, Victoria
(03) 4215 3320
Austin Health, Heidelberg, Victoria
(03) 9496 3351
Ramsay Clinic Albert Road, Melbourne, Victoria
(03) 9279 3518

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
Deakin University
Registry
ClinicalTrials.gov
Start date
26 August 2024
Est. completion
1 May 2027

Where this trial is recruiting

🇦🇺 Australia

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

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: 26 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