Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of TSND-201 for PTSD Treatment
Led by Transcend Therapeutics · Updated on 2026-05-20
300
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TSND-201 in adults diagnosed with Post Traumatic Stress Disorder (PTSD). This Phase 3 clinical trial aims to compare two different doses of TSND-201 against a placebo to better understand its impact on PTSD symptoms. Participants must have had PTSD symptoms for at least six months and have tried at least one previous treatment. Participants will be randomly assigned to one of three groups: one receiving TSND-201 at Dose Level 1, another receiving TSND-201 at Dose Level 2, and the third receiving a placebo. Each participant will take capsules orally once a week for four consecutive weeks during the Treatment Period. After this, they will enter an 8-week Follow-up Period where no study drug is given, but their condition will continue to be monitored. During the study, participants will undergo regular assessments including the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) to measure changes in PTSD symptom severity up to 12 weeks. The study includes careful safety monitoring and requires participants to communicate well enough to complete interviews and questionnaires. The total duration of participation covers the 4-week treatment plus the 8-week follow-up, allowing researchers to observe both immediate and lasting effects of the treatment.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Meet DSM-5 criteria for current PTSD with symptoms lasting at least 6 months
- Have tried at least one pharmacological treatment or trauma-focused psychotherapy for PTSD
- Able to communicate verbally and read to complete 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 and above
- Unable to refrain from nicotine use for at least 8 hours
- Use of prohibited concomitant medications or therapies
- Current or past clinically significant cardiovascular or cerebrovascular conditions, including uncontrolled hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive TSND-201 or placebo capsules orally once a week for four consecutive weeks.
4 weekly visits (in-person)
Duration - Up to 8 weeks after treatment
Participants are monitored to assess the safety and efficacy of treatment up to 12 weeks from baseline.
Periodic visits up to 12 weeks total duration
Trial Site Locations
Total: 26 locations
1
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Kadima Neuropsychiatry
La Jolla, California, United States, 92037
Actively Recruiting
3
CalNeuro Research Group
Los Angeles, California, United States, 90025
Actively Recruiting
4
Catalina Research Institute
Montclair, California, United States, 91763
Actively Recruiting
5
Excell Research
Oceanside, California, United States, 92056
Actively Recruiting
6
Inland Psychiatric Medical Group
San Juan Capistrano, California, United States, 92675
Actively Recruiting
7
Starlight Clinical Research
Evergreen, Colorado, United States, 80439
Actively Recruiting
8
CNS Healthcare
Jacksonville, Florida, United States, 32256
Actively Recruiting
9
Segal Trials
Lauderhill, Florida, United States, 33319
Actively Recruiting
10
Accel Clinical Research
Maitland, Florida, United States, 32751
Actively Recruiting
11
CNS Healthcare
Orlando, Florida, United States, 32801
Actively Recruiting
12
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
13
Headlands Research - Pharmasite
Pikesville, Maryland, United States, 21208
Actively Recruiting
14
Vitalix Clinical
Worcester, Massachusetts, United States, 01608
Actively Recruiting
15
Midwest Research GRoup
Saint Charles, Missouri, United States, 63304
Actively Recruiting
16
Center for Emotional Fitness/ Lumina Clinical Research Center
Cherry Hill, New Jersey, United States, 08002
Actively Recruiting
17
Global Medical Institutes
Princeton, New Jersey, United States, 08540
Actively Recruiting
18
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
Actively Recruiting
19
Medical Research Network
New York, New York, United States, 10128
Actively Recruiting
20
Insight Clinical Trials
Independence, Ohio, United States, 44131
Actively Recruiting
21
Flourish Research
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
22
Suburban Research Associates
West Chester, Pennsylvania, United States, 19380
Actively Recruiting
23
Austin Clinical Trial Partners
Austin, Texas, United States, 78737
Actively Recruiting
24
Haracec Clinical Research
El Paso, Texas, United States, 79902
Actively Recruiting
25
Inner Space Research
Orem, Utah, United States, 84058
Actively Recruiting
26
Seattle Neuropsychiatric Treatment Center (NTC)
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
S
Study Director
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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