Trial studying safety and effects 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 oral capsule being studied as a potential treatment for post‑traumatic stress disorder (PTSD). TSND-201 is designed to increase levels of serotonin, dopamine, and norepinephrine in the brain by acting as a releasing agent.
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
- The study aims to find out whether TSND-201 is safe and works better than placebo for treating PTSD.
- Who it's for
- Adults who have been diagnosed with post‑traumatic stress disorder.
- What's involved
- Participants will be randomly assigned to receive either a low dose, a high dose of TSND-201, or a placebo once a week for four weeks.
- Time commitment
- The trial lasts about 12 weeks total, with weekly visits during the 4‑week treatment and follow‑up visits over the next 8 weeks.
- 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
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Imperial, California, 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
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Pikesville, Maryland, United States
- Worcester, Massachusetts, United States
+ 17 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 Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Imperial, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 31 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.