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Tests treatment safety and results for Post Traumatic Stress Disorder
Official title An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
ClinicalTrials.gov ID: NCT07456696
What this study is testing
What is TSND-201?
TSND-201 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for post traumatic stress disorder.
Also referred to as methylone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Oceanside, California, United States
- Orange, California, United States
- San Juan Capistrano, California, United States
- Evergreen, Colorado, United States
- Jacksonville, Florida, United States
- Lauderhill, Florida, United States
- Maitland, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Pikesville, Maryland, United States
- Worcester, Massachusetts, United States
- Creve Coeur, Missouri, United States
- Saint Charles, Missouri, United States
- Cherry Hill, New Jersey, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States; Montclair, California, United States; Oceanside, California, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.