TSND-201 treatment for PTSD in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial enrolls adults with PTSD who have tried other treatments. Participants are randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, administered weekly during a 4-week treatment period, followed by an 8-week follow-up. The study assesses safety and how well TSND-201 works for reducing PTSD symptoms. Key assessments include interviews and questionnaires to monitor response and adverse effects. Locations include sites in Colorado and Florida, sponsored by Transcend Therapeutics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
* Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
* Free from any other clinically significant illness or disease.

Exclusion Criteria:

* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2.
* Unable to refrain from nicotine use for at least 8 hours.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.

Where it's running

• Mountain View Clinical Research
  Denver, Colorado, United States Recruiting
• Bradenton Research Center
  Bradenton, Florida, United States Recruiting
• CNS Healthcare
  Orlando, Florida, United States Recruiting
• CenExel Tampa
  Tampa, Florida, United States Recruiting
• K2 Medical Research Tampa
  Tampa, Florida, United States Recruiting
• CenExel Atlanta
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: amanda@transcendtherapeutics.com
• Phone: 650-769-6472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.