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TSND-201 treatment for adults with PTSD (EMPOWER-1)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Phase 3 Interventional Transcend Therapeutics · NCT07456696

This test tries to see if weekly doses of TSND-201 reduce PTSD symptoms in adults who have had PTSD for at least six months and tried prior treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorTranscend Therapeutics Industry-sponsored
Locations19 sites (Little Rock, Arkansas and 18 other locations)
Trial IDNCT07456696 on ClinicalTrials.gov

What this trial studies

EMPOWER-1 is a Phase 3, randomized, double-blind trial that assigns eligible adults with DSM-5 PTSD 1:1:1 to one of two doses of TSND-201 or placebo given once weekly during a 4-week treatment period, followed by an 8-week follow-up. Participants must have had PTSD symptoms for at least six months and previously tried at least one pharmacologic treatment or trauma-focused psychotherapy. Key exclusions include a primary diagnosis other than PTSD, significant cardiovascular or cerebrovascular disease (including uncontrolled hypertension), extreme BMI (<18 or ≥40 kg/m2), use of prohibited concomitant therapies, or inability to refrain from nicotine as required. Safety and symptom change over the treatment and follow-up periods are the main outcomes.

Who should consider this trial

Good fit: Adults meeting DSM-5 criteria for current PTSD for at least six months who have tried at least one medication or trauma-focused psychotherapy, can complete interviews and questionnaires, and meet the trial's medical eligibility are ideal candidates.

Not a fit: People with a primary non-PTSD DSM-5 diagnosis, clinically significant cardiovascular or cerebrovascular disease, extreme BMI, inability to stop prohibited medications or nicotine use, or other disqualifying medical conditions are unlikely to benefit or are ineligible for this trial.

Why it matters

Potential benefit: If successful, TSND-201 could offer a new once-weekly medication option that reduces PTSD symptoms for adults who have not fully responded to existing treatments.

How similar studies have performed: This Phase 3 follows earlier-phase testing of TSND-201 and related neuroplastogen approaches that produced preliminary positive safety and efficacy signals but are not yet established as standard treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Little Rock, Arkansas and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Post Traumatic Stress DisorderPTSDEMPOWER-1Transcend TherapeuticsTSND-201Neuroplastogen
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.