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RecruitingPhase 3

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

Transcend Therapeutics · NCT07456696

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
300
US sites recruiting
37
Study start
April 2, 2026
Record last updated
September 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TSND-201; Placebo

Conditions: Post Traumatic Stress Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Mountain Clinical Trials LLC

    Phoenix, AZ 85050

    Site contact: Anna Crossland · 602-767-2612 · Annamaria@MountainClinicalTrials.com

  • Del Sol Research

    Tucson, AZ 85715

    Site contact: Wendy Hotz, President, R. Ph. · (520) 481-8464 · whotz@delsolresearch.com

  • Preferred Research Partners

    Little Rock, AR 72211

    Site contact: Study Coordinator · 501-553-9987

  • Sun Valley Research

    Imperial, CA 92251

    Site contact: Recruitment Department · 760-545-0123 · svrcinfo@sunvalleyb.com

  • Kadima Neuropsychiatry

    La Jolla, CA 92037

    Site contact: David Feifel, MD, PhD · (858) 412- 4130

  • CalNeuro Research Group

    Los Angeles, CA 90025

    Site contact: Michelle Piesman, Study Coordinator · 310-208-7144 · mpiesman@calneuroresearch.com

  • Catalina Research Institute

    Montclair, CA 91763

    Site contact: Rachelle Phillips, Site Director · rachelle.phillips@empathxresearch.com

  • Excell Research

    Oceanside, CA 92056

    Site contact: James Lamb · 760-758-2222 · jlamb@excellresearch.com

  • ATP Clinical Research

    Orange, CA 92866

    Site contact: Bobby Shih, Site Manager · 949-354-5353 · bshih@atpcr.com

  • Inland Psychiatric Medical Group

    San Juan Capistrano, CA 92675

    Site contact: Vanessa Montanez · 909-955-5865 · vanessa.montanez@inlandpsych.com

  • Starlight Clinical Research

    Evergreen, CO 80439

    Site contact: David Canter, Co-Founder · 970-420-5804 · study@starlightclinicalresearch.com

  • CNS Healthcare

    Jacksonville, FL 32256

    Site contact: Study Coordinator · 904-281-5757

  • Segal Trials

    Lauderhill, FL 33319

    Site contact: Leandro Rueda · lrueda@segaltrials.com

  • Accel Clinical Research

    Maitland, FL 32751

    Site contact: Ashley Thompson, Clinical Operations Manager · 407-644-1165 · ashley.thompson@accelclinical.com

  • CNS Healthcare

    Orlando, FL 32801

    Site contact: Ashley Westerfeld · awesterfeld@cnshealthcare.com

  • TrialMed

    Atlanta, GA 30328

    Site contact: Jennifer Flemming · 404-255-6005 · jennifer.fleming@thermofisher.com

  • Uptown Research Institute

    Chicago, IL 60640

    Site contact: Stephen Schneider · sschneider@uptownresearch.com

  • DelRicht - New Orleans

    New Orleans, LA 70115

    Site contact: Anne Wright · 504-336-2667

  • Headlands Research - Pharmasite

    Pikesville, MD 21208

    Site contact: Surya Korn · 410-497-8915 · surya.korn@pharmasiteresearch.com

  • Vitalix Clinical

    Worcester, MA 01608

    Site contact: Rajvi Patel · 508-723-3730 · rpatel@vitalixclinical.com

  • Arch Clinical Trials

    Creve Coeur, MO 63141

    Site contact: Israa Diab, Clinical Director · (314) 282-3521 · idiab@archclinicaltrials.com

  • Midwest Research Group

    Saint Charles, MO 63304

    Site contact: Lindsay Van Winkle · 636-496-8032 ext. 5 · lvanwinkle@midwestresearchgroup.com

  • Center for Emotional Fitness/ Lumina Clinical Research Center

    Cherry Hill, NJ 08002

    Site contact: Jennifer Mellon · 856-857-9500 · jmellon@luminacrc.com

  • Global Medical Institutes

    Princeton, NJ 08540

    Site contact: Thibaud Belleface, Recruitment Specialist · 609-921-3555 · tbelleface@gminstitutes.com

  • Bio Behavioral Health

    Toms River, NJ 08755

    Site contact: Jessica Sutton · 732-244-2299 · jessica@bbhnj.com

  • Medical Research Network

    New York, NY 10128

    Site contact: Matt Turzilli · (212) 595-5012 · matthew.turzilli@imaresearch.com

  • Insight Clinical Trials

    Independence, OH 44131

    Site contact: Elisa Poggi · 216-526-1843

  • Flourish Research

    Plymouth Meeting, PA 19462

    Site contact: Landon Este · 610-277-8073

  • Suburban Research Associates

    West Chester, PA 19380

    Site contact: Head of Site Operations · 601-891-9024 · info@suburbanresearch.com

  • CNS Memphis

    Memphis, TN 38119

    Site contact: Haley Edmonds · 901-843-1045 · hedmonds@cnshealthcare.com

  • Austin Clinical Trial Partners

    Austin, TX 78737

    Site contact: Kara Chilek · 512-521-0595

  • Haracec Clinical Research

    El Paso, TX 79902

    Site contact: Aghaegbulam Uga, MD · 915-200-1144 · auga@haracechealth.com

  • Elevate Clinical Research

    Houston, TX 77058

    Site contact: Matthew Brams, MD. · 832-240-9765 · mbrams@elevateclinical.com

  • Cedar Clinical Research

    Draper, UT 84020

    Site contact: Maria Castro · maria.castro@numinusnetwork.com

  • Inner Space Research

    Orem, UT 84058

    Site contact: Inner Space Research · 801-871-5516 · apply@innerspaceresearch.com

  • Seattle Neuropsychiatric Treatment Center (NTC)

    Seattle, WA 98104

    Site contact: Seattle NTC Research Team · 206-467-6300 · empower@seattlentc.com

  • Wisconsin-Madison

    Madison, WI 53706

    Site contact: Christopher Nicholas, PhD · 608-444-2397 · empoweruw@fammed.wisc.edu

Study contacts (from the official record)

  • Study Director · 650-769-6472 · amanda@transcendtherapeutics.com
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An Evaluation of the Safety and Efficacy of TSND-201 for the… (NCT07456696) | Bored Studies