Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing TSND-201 for Post Traumatic Stress Disorder

This study is evaluating the safety and how well it works of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomly assigned 1:1:1 to receive one of two doses of TSND-201 or dummy treatment (placebo), once per week.

Official registry: https://clinicaltrials.gov/study/NCT07836647 · Transcend Therapeutics · enrollment listed as 300

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TSND-201, or Placebo. The registry lists allocation as randomized. This study is evaluating the safety and how well it works of TSND-201 in adults with PTSD.

They plan to enroll about 300 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Interventions: TSND-201, Placebo

Primary outcome (registry wording): Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Study Director

650-769-6472

amanda@transcendtherapeutics.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseChicago, Illinois
Not a traditional drug phase: real iTBS for Mild Traumatic Brain Injury

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.

NCT03819608 · Official ClinicalTrials.gov record · Northwestern University

RecruitingNot a traditional drug phaseRichmond, Virginia
Not a traditional drug phase: Antioxidant for Peripheral Vascular Diseases

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

NCT04916327 · Official ClinicalTrials.gov record · Virginia Commonwealth University

FAQ about this NCT record

Is NCT07836647 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07836647?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07836647?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary