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TSND-201 for Post-Traumatic Stress Disorder (PTSD)

This study, called EMPOWER-1, is looking at how safe and effective an oral medication called TSND-201 is for adults with Post-Traumatic Stress Disorder (PTSD). You might be able to join if you are 18 or older, have had PTSD symptoms for at least 6 months, and have already tried another PTSD treatment. Participants will take TSND-201 or a placebo (an inactive pill) once a week for four weeks. Researchers will measure changes in your PTSD symptoms using a standard questionnaire (CAPS-5) to see if TSND-201 helps. The study aims to enroll 300 people, but its current status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive one of two doses of TSND-201 or a placebo. Approximately 300 participants are planned for this study.
What's involved
You would take capsules once a week for four consecutive weeks. After this, there will be an 8-week follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks after the 4-week treatment period, with symptom changes measured up to 12 weeks.

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NCT07456696

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Transcend Therapeutics
~300 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:TSND-201Placebo

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Measured over Up to 12 weeks

Conditions

Post Traumatic Stress Disorder

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

32 sites across 17 states
California6
Florida4
New Jersey3
Texas3
Missouri2
Pennsylvania2
Utah2
Arizona1

Who to contact

Study Director
[email protected]
650-769-6472
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Meets the 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

Primary diagnosis of any other DSM-5 disorder.
Body mass index (BMI) \<18 kg/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 trial measures

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity ScoreUp to 12 weeks

    CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.