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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Transcend Therapeutics
Where
Atlanta, Bradenton, Denver, Draper, Marlton, Orlando, Tampa, and Toms River, United StatesSee the 9 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
25 Sept 2026
Expected to end
Feb 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • TSND-201
  • Placebo
Record updated
3 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of prohibited concomitant medications or therapies
  • Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions
  • 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

Where in United States

  • CenExel AtlantaAtlanta, United StatesContact: Elyssa Barron, MDTaking people
  • Bradenton Research CenterBradenton, United StatesContact: Gloria Carlbert, Site DirectorTaking people
  • Mountain View Clinical ResearchDenver, United StatesContact: Brian JohnsonTaking people
  • Cedar Clinical ResearchDraper, United StatesContact: Maria CastroTaking people
  • CenExel MarltonMarlton, United StatesContact: Lisa WilkinsTaking people
  • CNS HealthcareOrlando, United StatesContact: Ashley WesterfeldTaking people
  • Cenexel TampaTampa, United StatesContact: Jennifer CruzTaking people
  • K2 Medical Research - TampaTampa, United StatesContact: Brooke InaTaking people
  • Bio Behavioral HealthToms River, United StatesContact: Jessica SuttonTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • TSND-201, Dose Level 1Treatment being tested

    Treatment: TSND-201

  • TSND-201, Dose Level 2Treatment being tested

    Treatment: TSND-201

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
Record updated
3 November 2026