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RecruitingNCT07836647EMPOWER-2Updated Sep 23, 2026

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

A Phase 3 interventional study of TSND-201 and Placebo in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Transcend Therapeutics · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Post Traumatic Stress Disorder

Keywords

  • PTSD
  • EMPOWER-2
  • Transcend Therapeutics
  • TSND-201
  • Neuroplastogen
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    TSND-201, Dose Level 1

    Drug: TSND-201

  • Experimental
    TSND-201, Dose Level 2

    Drug: TSND-201

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTSND-201

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

    Also known as: methylone

  • DrugPlacebo

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

05

What researchers measure

Primary outcomes

  1. Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

    CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

    Time frame: Up to 12 Weeks

06

Study locations

2 of 2 sites recruiting
  • Mountain View Clinical Research
    Denver, Colorado 80209, United States
    Recruiting
  • Bradenton Research Center
    Bradenton, Florida 34205, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07836647
Lead sponsor
Transcend Therapeutics
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Study Director
Contact
amanda@transcendtherapeutics.com
650-769-6472

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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