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Promising PTSD drug moves to Long-Term safety study

NCT ID NCT07670702

Disease control 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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 1 time

Summary

This study is testing the long-term safety and effectiveness of a drug called TSND-201 for adults with PTSD. Participants who completed an earlier blinded trial of TSND-201 can receive up to three treatment courses over 48 weeks, each consisting of four weekly doses. The goal is to see if the drug can reduce PTSD symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TSND-201 (a drug taken as capsules once a week for four weeks per treatment course)
What this could lead to
If it works, this could provide a new treatment option for PTSD that reduces symptoms over the long term.
What could go wrong
This is an open-label extension study, meaning everyone knows they are getting the drug, which can bias results. It is also limited to people who already tolerated the drug in a prior trial, so side effects or lack of benefit in a broader population are still possible.

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

Jun 2026

Expected to finish

Jan 2029

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site. * Proficient in communication (verbal and reading) to complete interviews and written questionnaires. * Agree to not participate in any other interventional clinical trials for the duration of this study. Exclusion Criteria: * Experienced an intolerable side effect following dosing with TSND-201 in the prior study. * Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation. * Change or development of any physical or psychological finding that would make participant unsuitable for study.

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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 places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Accel Clinical Research

    Maitland, Florida, 32751, United States

  • Arch Clinical Trials

    Creve Coeur, Missouri, 63141, United States

  • Austin Clinical Trial Partners

    Austin, Texas, 78737, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • CNS Healthcare

    Orlando, Florida, 32801, United States

  • CalNeuro Research Group

    Los Angeles, California, 90025, United States

  • Catalina Research Institute

    Montclair, California, 91763, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256, United States

  • Flourish Research

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Haracec Clinical Research

    El Paso, Texas, 79902, United States

  • Inner Space Research

    Orem, Utah, 84058, United States

  • Insight Clinical Trials

    Independence, Ohio, 44131, United States

  • Preferred Research Partners

    Little Rock, Arkansas, 72211, United States

  • Segal Trials

    Lauderhill, Florida, 33319, United States

  • Starlight Clinical Research

    Evergreen, Colorado, 80439, United States

  • Vitalix Clinical

    Worcester, Massachusetts, 01608, United States

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