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Study identifier: NCT07456696 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: RecruitingEMPOWER-1

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

Condition: Post Traumatic Stress Disorder  ·  Sponsor: Transcend Therapeutics

PhasePhase 3
Planned participants300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where32 locations

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Study Director  ·  650-769-6472  ·  amanda@transcendtherapeutics.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (32)

Del Sol ResearchTucson, Arizona, United StatesRecruiting
Preferred Research PartnersLittle Rock, Arkansas, United StatesRecruiting
Kadima NeuropsychiatryLa Jolla, California, United StatesRecruiting
CalNeuro Research GroupLos Angeles, California, United StatesRecruiting
Catalina Research InstituteMontclair, California, United StatesRecruiting
Excell ResearchOceanside, California, United StatesRecruiting
ATP Clinical ResearchOrange, California, United StatesRecruiting
Inland Psychiatric Medical GroupSan Juan Capistrano, California, United StatesRecruiting
Starlight Clinical ResearchEvergreen, Colorado, United StatesRecruiting
CNS HealthcareJacksonville, Florida, United StatesRecruiting
Segal TrialsLauderhill, Florida, United StatesRecruiting
Accel Clinical ResearchMaitland, Florida, United StatesRecruiting

+ 20 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

TucsonLittle RockLa JollaLos Angeles

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