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New PTSD drug shows promise in Large-Scale trial

NCT ID NCT07456696

Symptom relief Sponsor: Transcend Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests whether a new drug called TSND-201 can safely reduce PTSD symptoms in adults. About 300 people with PTSD will receive either one of two doses of TSND-201 or a placebo once a week for 4 weeks, then be followed for 8 more weeks. The goal is to see if the drug helps lower the severity of PTSD symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post traumatic stress disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    37 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Accel Clinical Research

    RECRUITING

    Maitland, Florida, 32751, United States

  • Arch Clinical Trials

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

  • Austin Clinical Trial Partners

    RECRUITING

    Austin, Texas, 78737, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • CNS Healthcare

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • CNS Healthcare

    RECRUITING

    Orlando, Florida, 32801, United States

  • CNS Memphis

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • CalNeuro Research Group

    RECRUITING

    Los Angeles, California, 90025, United States

  • Catalina Research Institute

    RECRUITING

    Montclair, California, 91763, United States

  • Cedar Clinical Research

    RECRUITING

    Draper, Utah, 84020, United States

  • Center for Emotional Fitness/ Lumina Clinical Research Center

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Del Sol Research

    RECRUITING

    Tucson, Arizona, 85715, United States

  • DelRicht - New Orleans

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Elevate Clinical Research

    RECRUITING

    Houston, Texas, 77058, United States

  • Excell Research

    RECRUITING

    Oceanside, California, 92056, United States

  • Flourish Research

    RECRUITING

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Global Medical Institutes

    RECRUITING

    Princeton, New Jersey, 08540, United States

  • Haracec Clinical Research

    RECRUITING

    El Paso, Texas, 79902, United States

  • Headlands Research - Pharmasite

    RECRUITING

    Pikesville, Maryland, 21208, United States

  • Inland Psychiatric Medical Group

    RECRUITING

    San Juan Capistrano, California, 92675, United States

  • Inner Space Research

    RECRUITING

    Orem, Utah, 84058, United States

  • Insight Clinical Trials

    RECRUITING

    Independence, Ohio, 44131, United States

  • Kadima Neuropsychiatry

    RECRUITING

    La Jolla, California, 92037, United States

  • Medical Research Network

    RECRUITING

    New York, New York, 10128, United States

  • Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Mountain Clinical Trials LLC

    RECRUITING

    Phoenix, Arizona, 85050, United States

  • Preferred Research Partners

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Seattle Neuropsychiatric Treatment Center (NTC)

    RECRUITING

    Seattle, Washington, 98104, United States

  • Segal Trials

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • Starlight Clinical Research

    RECRUITING

    Evergreen, Colorado, 80439, United States

    Contact Email: •••••@•••••

  • Suburban Research Associates

    RECRUITING

    West Chester, Pennsylvania, 19380, United States

    Contact Email: •••••@•••••

  • Sun Valley Research

    RECRUITING

    Imperial, California, 92251, United States

    Contact Email: •••••@•••••

  • TrialMed

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Uptown Research Institute

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Vitalix Clinical

    RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Wisconsin-Madison

    RECRUITING

    Madison, Wisconsin, 53706, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.