An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
EMPOWER-1
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
1 other identifier
interventional
300
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2026
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
April 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 12, 2026
May 1, 2026
1.7 years
March 2, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Up to 12 weeks
Study Arms (3)
TSND-201, Dose Level 1
EXPERIMENTALTSND-201, Dose Level 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Del Sol Research
Tucson, Arizona, 85715, United States
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
Kadima Neuropsychiatry
La Jolla, California, 92037, United States
CalNeuro Research Group
Los Angeles, California, 90025, United States
Catalina Research Institute
Montclair, California, 91763, United States
Excell Research
Oceanside, California, 92056, United States
ATP Clinical Research
Orange, California, 92866, United States
Inland Psychiatric Medical Group
San Juan Capistrano, California, 92675, United States
Starlight Clinical Research
Evergreen, Colorado, 80439, United States
CNS Healthcare
Jacksonville, Florida, 32256, United States
Segal Trials
Lauderhill, Florida, 33319, United States
Accel Clinical Research
Maitland, Florida, 32751, United States
CNS Healthcare
Orlando, Florida, 32801, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
DelRicht - New Orleans
New Orleans, Louisiana, 70115, United States
Headlands Research - Pharmasite
Pikesville, Maryland, 21208, United States
Vitalix Clinical
Worcester, Massachusetts, 01608, United States
Arch Clinical Trials
Creve Coeur, Missouri, 63141, United States
Midwest Research Group
Saint Charles, Missouri, 63304, United States
Center for Emotional Fitness/ Lumina Clinical Research Center
Cherry Hill, New Jersey, 08002, United States
Global Medical Institutes
Princeton, New Jersey, 08540, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Medical Research Network
New York, New York, 10128, United States
Insight Clinical Trials
Independence, Ohio, 44131, United States
Flourish Research
Plymouth Meeting, Pennsylvania, 19462, United States
Suburban Research Associates
West Chester, Pennsylvania, 19380, United States
Austin Clinical Trial Partners
Austin, Texas, 78737, United States
Haracec Clinical Research
El Paso, Texas, 79902, United States
Elevate Clinical Research
Houston, Texas, 77058, United States
Cedar Clinical Research
Draper, Utah, 84020, United States
Inner Space Research
Orem, Utah, 84058, United States
Seattle Neuropsychiatric Treatment Center (NTC)
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2026
First Posted
March 6, 2026
Study Start
April 2, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share