Post Traumatic Stress DisorderPhase 3EMPOWER-2NCT07836647
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
A Phase 3 study testing TSND-201 in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- TSND-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Sep 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
CenExel Atlanta
Atlanta, Georgia, 30331
Elyssa Barron, MD, 404-881-5800
- Recruiting
Bradenton Research Center
Bradenton, Florida, 34205
Gloria Carlbert, Site Director, 941-708-0005, gloriacarlbert@bradentonresearch.com
- Recruiting
Mountain View Clinical Research
Denver, Colorado, 80209
Brian Johnson, 720-941-9363 ext. 2, brian@mtnresearch.com
- Recruiting
Cedar Clinical Research
Draper, Utah, 84020
Maria Castro, maria.castro@numinusnetwork.com
- Recruiting
CenExel Marlton
Marlton, New Jersey, 08053
Lisa Wilkins, 888-437-4104
- Recruiting
CNS Healthcare
Orlando, Florida, 32801
Ashley Westerfeld, awesterfeld@cnshealthcare.com
- Recruiting
CenExel Tampa
Tampa, Florida, 33613
Jennifer Cruz, j.cruz@cenexel.com
- Recruiting
K2 Medical Research Tampa
Tampa, Florida, 33634
Brooke Ina, brooke.ina@k2med.com
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
Jessica Sutton, 732-244-2299, jessica@bbhnj.com
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
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
- Being tested
- TSND-201, Placebo
- Keywords
- PTSD, EMPOWER-2, Transcend Therapeutics, TSND-201, Neuroplastogen
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSND-201Drug
Also called methylone
TSND-201 capsules, given orally, once a week for four consecutive weeks
PlaceboDrug
Placebo capsules, given orally, once a week for four consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| TSND-201, Dose Level 1 | Experimental | Not described Receives: Drug: TSND-201 |
| TSND-201, Dose Level 2 | Experimental | Not described Receives: Drug: TSND-201 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start25 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836647
- Sponsor's protocol ID
- TSND201-PTSD-302
- Acronym
- EMPOWER-2
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT07836647
- Acronym / sponsor ID
- EMPOWER-2 / TSND201-PTSD-302
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, EMPOWER-2, Transcend Therapeutics, TSND-201, Neuroplastogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TSND-201, Dose Level 1 | Experimental | Drug: TSND-201 |
| TSND-201, Dose Level 2 | Experimental | Drug: TSND-201 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSND-201Also: methyloneTSND-201 capsules, given orally, once a week for four consecutive weeks | Drug | TSND-201, Dose Level 1, TSND-201, Dose Level 2 |
| PlaceboPlacebo capsules, given orally, once a week for four consecutive weeks | Drug | Placebo |
Primary outcome
Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Time frame: Up to 12 Weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TSND-201 in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (650-769-6472, amanda@transcendtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.