An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
- Post Traumatic Stress Disorder
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Transcend Therapeutics
- Enrolment target
- 300
- Started
- September 2026
- Main results due
- February 2028
- Study sites
- 2
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.
Study sites(2)
Mountain View Clinical Research
Denver, Colorado, United States
Recruiting
Bradenton Research Center
Bradenton, Florida, United States
Recruiting
Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07836647. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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