Recruiting
Phase 3

TSND-201

Sponsor:

Transcend Therapeutics

Code:

NCT07836647

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TSND-201

Placebo

Study Details

Brief 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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT07836647

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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-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) <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 (including current uncontrolled hypertension) / cerebrovascular conditions.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TSND-201, Dose Level 1

experimental: TSND-201, Dose Level 2

placebo comparator: Placebo

Interventions

TSND-201

TSND-201 capsules, given orally, once a week for four consecutive weeks

Placebo

Placebo capsules, given orally, once a week for four consecutive weeks

Primary outcome measure

  • Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score [ Time Frame: Up to 12 Weeks ]

Central Contacts and Locations

Central contacts

Study Director

650-769-6472amanda@transcendtherapeutics.com

Locations

Mountain View Clinical Research

Recruiting

Denver, Colorado, United States, 80209

Contacts

Brian Johnson

720-941-9363brian@mtnresearch.com

Bradenton Research Center

Recruiting

Bradenton, Florida, United States, 34205

Contacts

Gloria Carlbert, Site Director

941-708-0005gloriacarlbert@bradentonresearch.com

More Information

Sponsor

Transcend Therapeutics

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • PTSD
  • EMPOWER-2
  • Transcend Therapeutics
  • TSND-201
  • Neuroplastogen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Transcend Therapeutics on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.