An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD

Last updated: November 1, 2026
Sponsor: Transcend Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Post-traumatic Stress Disorders

Treatment

TSND-201

Placebo

Clinical Study ID

NCT07836647
TSND201-PTSD-302
  • Ages > 18
  • All Genders

Study Summary

This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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-focusedpsychotherapy.

  • Proficient in communication (verbal and reading) to complete interviews and writtenquestionnaires.

  • Free from any other clinically significant illness or disease.

Exclusion

Exclusion Criteria:

  • 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 (includingcurrent uncontrolled hypertension) / cerebrovascular conditions.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: TSND-201
Phase: 3
Study Start date:
September 25, 2026
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Mountain View Clinical Research

    Denver, Colorado 80209
    United States

    Active - Recruiting

  • Bradenton Research Center

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • CNS Healthcare

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • CenExel Tampa

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • K2 Medical Research Tampa

    Tampa, Florida 33634
    United States

    Active - Recruiting

  • CenExel Atlanta

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • CenExel Marlton

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • Bio Behavioral Health

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Active - Recruiting

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