Post Traumatic Stress Disorder study: TSND-201
Official title An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
ClinicalTrials.gov ID: NCT07836647
What this study is testing
What is TSND-201?
TSND-201 is an investigational medicine, taken by mouth once weekly, 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 aims to find out if the drug TSND-201 is safe and effective for treating Post-Traumatic Stress Disorder (PTSD).
- Who it's for
- The study is looking for adults who have been diagnosed with PTSD.
- What's involved
- Participants will receive one weekly dose of either TSND-201 or a placebo (a pill with no active medicine) for four weeks.
- Time commitment
- The study lasts 12 weeks, involving weekly visits for four weeks followed by an eight-week follow-up period.
- 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 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) \<18kg/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 is enrolling
- Denver, Colorado, United States
- Bradenton, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Marlton, New Jersey, United States
- Toms River, New Jersey, United States
- Draper, Utah, United States
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, but 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?
This study is enrolling now at Denver, Colorado, United States; Bradenton, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Marlton, New Jersey, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.