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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Transcend Therapeutics
Where
Atlanta, Austin, Cherry Hill, Chicago, Creve Coeur, Draper, El Paso, Evergreen, Houston, Imperial, Independence, Jacksonville, La Jolla, Lauderhill, Little Rock, Los Angeles, Madison, Maitland, Memphis, Montclair, New Orleans, New York, Oceanside, Orange, Orem, Orlando, Phoenix, Pikesville, Plymouth Meeting, Princeton, Saint Charles, San Juan Capistrano, Seattle, Toms River, Tucson, West Chester, and Worcester, United StatesSee the 37 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
2 Apr 2026
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • TSND-201
  • Placebo
Record updated
17 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of prohibited concomitant medications or therapies
  • Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions
  • 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

Where in United States

  • TrialmedAtlanta, United StatesContact: Jennifer FlemmingTaking people
  • Austin Clinical Trial PartnersAustin, United StatesContact: Kara ChilekTaking people
  • Center for Emotional Fitness/ Lumina Clinical Research CenterCherry Hill, United StatesContact: Jennifer MellonTaking people
  • Uptown Research InstituteChicago, United StatesContact: Stephen SchneiderTaking people
  • Arch Clinical TrialsCreve Coeur, United StatesContact: Israa Diab, Clinical DirectorTaking people
  • Cedar Clinical ResearchDraper, United StatesContact: Maria CastroTaking people
  • Haracec Clinical ResearchEl Paso, United StatesContact: Aghaegbulam Uga, MDTaking people
  • Starlight Clinical ResearchEvergreen, United StatesContact: David Canter, Co-FounderTaking people
  • Elevate Clinical ResearchHouston, United StatesContact: Matthew Brams, MD.Taking people
  • Sun Valley ResearchImperial, United StatesContact: Recruitment DepartmentTaking people
  • Insight Clinical TrialsIndependence, United StatesContact: Elisa PoggiTaking people
  • CNS HealthcareJacksonville, United StatesContact: Study CoordinatorTaking people
  • Kadima NeuropsychiatryLa Jolla, United StatesContact: David Feifel, MD, PhDTaking people
  • Segal TrialsLauderhill, United StatesContact: Leandro RuedaTaking people
  • Preferred Research PartnersLittle Rock, United StatesContact: Study CoordinatorTaking people
  • CalNeuro Research GroupLos Angeles, United StatesContact: Michelle Piesman, Study CoordinatorTaking people
  • Wisconsin-MadisonMadison, United StatesContact: Christopher Nicholas, PhDTaking people
  • Accel Clinical ResearchMaitland, United StatesContact: Ashley Thompson, Clinical Operations ManagerTaking people
  • CNS MemphisMemphis, United StatesContact: Haley EdmondsTaking people
  • Catalina Research InstituteMontclair, United StatesContact: Rachelle Phillips, Site DirectorTaking people
  • DelRicht - New OrleansNew Orleans, United StatesContact: Anne WrightTaking people
  • Medical Research NetworkNew York, United StatesContact: Matt TurzilliTaking people
  • Excell ResearchOceanside, United StatesContact: James LambTaking people
  • ATP Clinical ResearchOrange, United StatesContact: Bobby Shih, Site ManagerTaking people
  • Inner Space ResearchOrem, United StatesContact: Inner Space ResearchTaking people
  • CNS HealthcareOrlando, United StatesContact: Ashley WesterfeldTaking people
  • Mountain Clinical Trials LLCPhoenix, United StatesContact: Anna CrosslandTaking people
  • Headlands Research PharmasitePikesville, United StatesContact: Surya KornTaking people
  • Flourish ResearchPlymouth Meeting, United StatesContact: Landon EsteTaking people
  • Global Medical InstitutesPrinceton, United StatesContact: Thibaud Belleface, Recruitment SpecialistTaking people
  • Midwest Research GroupSaint Charles, United StatesContact: Lindsay Van WinkleTaking people
  • Inland Psychiatric Medical GroupSan Juan Capistrano, United StatesContact: Vanessa MontanezTaking people
  • Seattle Neuropsychiatric Treatment Center (NTC)Seattle, United StatesContact: Seattle NTC Research TeamTaking people
  • Bio Behavioral HealthToms River, United StatesContact: Jessica SuttonTaking people
  • Del Sol ResearchTucson, United StatesContact: Wendy Hotz, President, R. Ph.Taking people
  • Suburban Research AssociatesWest Chester, United StatesContact: Head of Site OperationsTaking people
  • Vitalix ClinicalWorcester, United StatesContact: Rajvi PatelTaking people

About the trial

What the trial wants to find out

This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • TSND-201, Dose Level 1Treatment being tested

    Treatment: TSND-201

  • TSND-201, Dose Level 2Treatment being tested

    Treatment: TSND-201

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Record updated
17 September 2026