Phase 1 PTSD Trial, Recruiting NCT06705296 Sponsor: Sunnybrook Health Sciences Centre Condition: PTSD
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Phase 1 PTSD Trial, Recruiting

NCT06705296
Recruiting Phase 1

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 to 70 years, of any gender
  • People who have been diagnosed with post-traumatic stress disorder (PTSD) according to current standard diagnostic guidelines (DSM-5)
  • People whose PTSD has not improved despite trying at least four types of treatment, including an antidepressant medication called an SSRI, cognitive behavioural therapy (a type of talk therapy), and at least one other medication or therapy type
  • People whose PTSD is considered severe, based on a specific clinical assessment score of 50 or higher on a scale called the CAPS
  • People whose PTSD symptoms have been ongoing and relatively stable for at least one year
  • People who are able to give informed consent and are willing and able to attend all appointments, tests, and follow-up visits required by the study

Who may not be able to join:

  • People with a past or current history of psychosis or mania (note: having depression alongside PTSD does not exclude someone from the trial)
  • People with an active neurological condition, such as epilepsy
  • People who have had problems with alcohol or substance use or dependence in the past six months (caffeine and nicotine are not included in this)
  • People who are currently experiencing thoughts of suicide
  • People for whom having an MRI or PET scan would not be medically safe
  • People who are likely to move to another country during the course of the study
  • People who have certain medical or neurological conditions that could significantly increase the risks associated with a surgical procedure involved in this trial
  • People who are currently pregnant or breastfeeding; women of childbearing potential are required to have been using a highly effective form of contraception for at least one month before the screening visit and to continue using it throughout the study

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 28 July 2026
Phase 1: approximately ~10% 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: Nir Lipsman, MD PhD, Sunnybrook Health Sciences Centre

Phone: 416-480-6100

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 1
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Number of participants with treatment-related adverse events as assessed by SAFTEE; Clinician-Administered PTSD Scale for DSM-5 (CAPS)

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: 28 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