Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07456696

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

Led by Transcend Therapeutics · Updated on 2026-05-05

300

Participants Needed

19

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets the DSM-5 criteria for current PTSD diagnosis, with symptoms lasting at least 6 months
  • Tried at least one pharmacological treatment or trauma-focused psychotherapy for PTSD
  • Able to communicate verbally and in writing to complete study interviews and questionnaires
  • Free from any other clinically significant illness or disease
Not Eligible

You will not qualify if you...

  • Primary diagnosis of any other DSM-5 disorder
  • Body mass index (BMI) less than 18 kg/m2 or 40 kg/m2 or higher
  • Unable to refrain from nicotine use for at least 8 hours
  • Use of prohibited medications or therapies
  • Current or past significant cardiovascular or cerebrovascular conditions, including uncontrolled hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Preferred Research Partners

Little Rock, Arkansas, United States, 72211

Actively Recruiting

2

CalNeuro Research Group

Los Angeles, California, United States, 90025

Actively Recruiting

3

Catalina Research Institute

Montclair, California, United States, 91763

Actively Recruiting

4

Inland Psychiatric Medical Group

San Juan Capistrano, California, United States, 92675

Actively Recruiting

5

Starlight Clinical Research

Evergreen, Colorado, United States, 80439

Actively Recruiting

6

CNS Healthcare

Jacksonville, Florida, United States, 32256

Actively Recruiting

7

Segal Trials

Lauderhill, Florida, United States, 33319

Actively Recruiting

8

Accel Clinical Research

Maitland, Florida, United States, 32751

Actively Recruiting

9

CNS Healthcare

Orlando, Florida, United States, 32801

Actively Recruiting

10

Uptown Research Institute

Chicago, Illinois, United States, 60640

Actively Recruiting

11

Vitalix Clinical

Worcester, Massachusetts, United States, 01608

Actively Recruiting

12

Midwest Research GRoup

Saint Charles, Missouri, United States, 63304

Actively Recruiting

13

Global Medical Institutes

Princeton, New Jersey, United States, 08540

Actively Recruiting

14

Bio Behavioral Health

Toms River, New Jersey, United States, 08755

Actively Recruiting

15

Insight Clinical Trials

Independence, Ohio, United States, 44131

Actively Recruiting

16

Suburban Research Associates

West Chester, Pennsylvania, United States, 19380

Actively Recruiting

17

Austin Clinical Trial Partners

Austin, Texas, United States, 78737

Actively Recruiting

18

Haracec Clinical Research

El Paso, Texas, United States, 79902

Actively Recruiting

19

Inner Space Research

Orem, Utah, United States, 84058

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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