Actively Recruiting
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
Eligibility Criteria
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
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
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
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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