Recruiting
Phase 3

TSND-201

Sponsor:

Transcend Therapeutics

Code:

NCT07456696

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TSND-201

Placebo

Study Details

Brief summary:

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT07456696

Start date

Apr 2, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TSND-201, Dose Level 1

experimental: TSND-201, Dose Level 2

placebo comparator: Placebo

Interventions

TSND-201

TSND-201 capsules, given orally, once a week for four consecutive weeks

Placebo

Placebo capsules, given orally, once a week for four consecutive weeks

Primary outcome measure

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Study Director

650-769-6472amanda@transcendtherapeutics.com

Locations

Del Sol Research

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Wendy Hotz, President, R. Ph.

(520) 481-8464whotz@delsolresearch.com

Preferred Research Partners

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

Study Coordinator

501-553-9987

Kadima Neuropsychiatry

Recruiting

La Jolla, California, United States, 92037

Contacts

David Feifel, MD, PhD

(858) 412- 4130

CalNeuro Research Group

Recruiting

Los Angeles, California, United States, 90025

Contacts

Michelle Piesman, Study Coordinator

310-208-7144mpiesman@calneuroresearch.com

Catalina Research Institute

Recruiting

Montclair, California, United States, 91763

Contacts

Rachelle Phillips, Site Director

rachelle.phillips@empathxresearch.com

Excell Research

Recruiting

Oceanside, California, United States, 92056

Contacts

James Lamb

760-758-2222jlamb@excellresearch.com

ATP Clinical Research

Recruiting

Orange, California, United States, 92866

Contacts

Bobby Shih, Site Manager

949-354-5353bshih@atpcr.com

Careline Lunter, Recruitment Coordinator

949-354-5353caralinel@pnsoc.com

Inland Psychiatric Medical Group

Recruiting

San Juan Capistrano, California, United States, 92675

Contacts

Vanessa Montanez

909-955-5865vanessa.montanez@inlandpsych.com

Starlight Clinical Research

Recruiting

Evergreen, Colorado, United States, 80439

Contacts

David Canter, Co-Founder

970-420-5804study@starlightclinicalresearch.com

CNS Healthcare

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Study Coordinator

904-281-5757

Segal Trials

Recruiting

Lauderhill, Florida, United States, 33319

Contacts

Leandro Rueda

lrueda@segaltrials.com

Accel Clinical Research

Recruiting

Maitland, Florida, United States, 32751

Contacts

Ashley Thompson, Clinical Operations Manager

407-644-1165ashley.thompson@accelclinical.com

CNS Healthcare

Recruiting

Orlando, Florida, United States, 32801

Contacts

Ashley Westerfeld

awesterfeld@cnshealthcare.com

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Stephen Schneider

sschneider@uptownresearch.com

DelRicht - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Anne Wright

504-336-2667

Headlands Research - Pharmasite

Recruiting

Pikesville, Maryland, United States, 21208

Contacts

Surya Korn

410-497-8915surya.korn@pharmasiteresearch.com

Vitalix Clinical

Recruiting

Worcester, Massachusetts, United States, 01608

Contacts

Rajvi Patel

508-723-3730rpatel@vitalixclinical.com

Arch Clinical Trials

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Israa Diab, Clinical Director

(314) 282-3521idiab@archclinicaltrials.com

Midwest Research Group

Recruiting

Saint Charles, Missouri, United States, 63304

Contacts

Lindsay Van Winkle

636-496-8032 ext. 5lvanwinkle@midwestresearchgroup.com

Center for Emotional Fitness/ Lumina Clinical Research Center

Recruiting

Cherry Hill, New Jersey, United States, 08002

Contacts

Jennifer Mellon

856-857-9500jmellon@luminacrc.com

Global Medical Institutes

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Thibaud Belleface, Recruitment Specialist

609-921-3555tbelleface@gminstitutes.com

Bio Behavioral Health

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Jessica Sutton

732-244-2299jessica@bbhnj.com

Medical Research Network

Recruiting

New York, New York, United States, 10128

Contacts

Matt Turzilli

(212) 595-5012matthew.turzilli@imaresearch.com

Insight Clinical Trials

Recruiting

Independence, Ohio, United States, 44131

Contacts

Elisa Poggi

216-526-1843

Flourish Research

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Contacts

Landon Este

610-277-8073

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Head of Site Operations

601-891-9024info@suburbanresearch.com

Austin Clinical Trial Partners

Recruiting

Austin, Texas, United States, 78737

Contacts

Kara Chilek

512-521-0595

Haracec Clinical Research

Recruiting

El Paso, Texas, United States, 79902

Contacts

Aghaegbulam Uga, MD

915-200-1144auga@haracechealth.com

Elevate Clinical Research

Recruiting

Houston, Texas, United States, 77058

Contacts

Matthew Brams, MD.

832-240-9765mbrams@elevateclinical.com

Cedar Clinical Research

Recruiting

Draper, Utah, United States, 84020

Contacts

Maria Castro

maria.castro@numinusnetwork.com

Inner Space Research

Recruiting

Orem, Utah, United States, 84058

Contacts

Inner Space Research

801-871-5516apply@innerspaceresearch.com

Seattle Neuropsychiatric Treatment Center (NTC)

Recruiting

Seattle, Washington, United States, 98104

Contacts

Seattle NTC Research Team

206-467-6300empower@seattlentc.com

More Information

Sponsor

Transcend Therapeutics

Last update posted

Jun 12, 2026

Last verified

May, 2026

Keywords

  • PTSD
  • EMPOWER-1
  • Transcend Therapeutics
  • TSND-201
  • Neuroplastogen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Transcend Therapeutics on 2026-06-12.