Phase 4 PTSD Trial, Recruiting NCT05853627 Sponsor: Massachusetts General Hospital Condition: PTSD
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Phase 4 PTSD Trial, Recruiting

NCT05853627
Recruiting Phase 4

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 65 who have been through a traumatic event that meets a specific clinical definition of trauma (known as DSM-5 PTSD Criterion A)
  • People who score above 33 on a standard PTSD symptom checklist called the PCL-5
  • People who show a specific physical (psychophysiological) response during a baseline test involving guided memory recall of their traumatic event — this is confirmed at the start of the trial before a place is confirmed
  • A formal diagnosis of PTSD is not required, though many participants are expected to meet that threshold based on the above criteria

Who may not be able to join:

  • People with a resting blood pressure below 90/60 mmHg or a resting heart rate below 50 beats per minute
  • People with certain heart or lung conditions such as congestive heart failure, heart block, chronic bronchitis, emphysema, or asthma (particularly if asthma occurred within the past ten years, was ever triggered by a beta-blocker medication, or is currently being treated)
  • People who have previously had a bad reaction to, or did not comply with, a type of medication called a beta-blocker
  • People currently taking medications that could interact dangerously with the study drug, including blood pressure medications, heart rhythm medications, or benzodiazepines
  • People who test positive for substances including opioids, marijuana, cocaine, amphetamines, or alcohol at the initial assessment
  • People who are pregnant or breastfeeding (women who could become pregnant will be given a pregnancy test at the initial assessment)
  • People with certain psychiatric conditions such as psychosis, bipolar disorder, melancholic depression, an active substance use disorder, or current suicidal thoughts
  • People who have started or changed a psychiatric medication within the past two months
  • People currently receiving any form of psychotherapy other than general supportive counselling
  • People who are unable to understand the study procedures, risks, and side effects, or who are unable to give informed consent
  • People who do not understand English, as the study procedures require detailed conversation with the research team

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 857.282.1724

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 4
Registry
ClinicalTrials.gov
Start date
15 June 2023
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.; Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.; Composite score of psychophysiological reactivity (comprising heart rate, skin conductance, and electromyography of the left corrugator muscle) using the Biopac system.

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