Post Traumatic Stress DisorderPhase 3EMPOWER-1NCT07456696
An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)
A Phase 3 study testing TSND-201 in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 37 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
- 37 sitesUnited States
- Study dates
- 2 Apr 2026to Dec 2027
- 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 the 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) <18 kg/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
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
United States37 sites, 37 recruiting
- Recruiting
TrialMed
Atlanta, Georgia, 30328
Jennifer Flemming, 404-255-6005, jennifer.fleming@thermofisher.com
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
Kara Chilek, 512-521-0595
- Recruiting
Center for Emotional Fitness/ Lumina Clinical Research Center
Cherry Hill, New Jersey, 08002
Jennifer Mellon, 856-857-9500 ext. 220, jmellon@luminacrc.com
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
Stephen Schneider, sschneider@uptownresearch.com
- Recruiting
Arch Clinical Trials
Creve Coeur, Missouri, 63141
Israa Diab, Clinical Director, (314) 282-3521, idiab@archclinicaltrials.com
- Recruiting
Cedar Clinical Research
Draper, Utah, 84020
Maria Castro, maria.castro@numinusnetwork.com
- Recruiting
Haracec Clinical Research
El Paso, Texas, 79902
Aghaegbulam Uga, MD, 915-200-1144, auga@haracechealth.com
- Recruiting
Starlight Clinical Research
Evergreen, Colorado, 80439
David Canter, Co-Founder, 970-420-5804, study@starlightclinicalresearch.com
- Recruiting
Elevate Clinical Research
Houston, Texas, 77058
Matthew Brams, MD., 832-240-9765, mbrams@elevateclinical.com
- Recruiting
Sun Valley Research
Imperial, California, 92251
Recruitment Department, 760-545-0123 ext. 108, svrcinfo@sunvalleyb.com
- Recruiting
Insight Clinical Trials
Independence, Ohio, 44131
Elisa Poggi, 216-526-1843
- Recruiting
CNS Healthcare
Jacksonville, Florida, 32256
Study Coordinator, 904-281-5757
- Recruiting
Kadima Neuropsychiatry
La Jolla, California, 92037
David Feifel, MD, PhD, (858) 412- 4130
- Recruiting
Segal Trials
Lauderhill, Florida, 33319
Leandro Rueda, lrueda@segaltrials.com
- Recruiting
Preferred Research Partners
Little Rock, Arkansas, 72211
Study Coordinator, 501-553-9987
- Recruiting
CalNeuro Research Group
Los Angeles, California, 90025
Michelle Piesman, Study Coordinator, 310-208-7144, mpiesman@calneuroresearch.com
- Recruiting
Wisconsin-Madison
Madison, Wisconsin, 53706
Christopher Nicholas, PhD, 608-444-2397, empoweruw@fammed.wisc.edu
- Recruiting
Accel Clinical Research
Maitland, Florida, 32751
Ashley Thompson, Clinical Operations Manager, 407-644-1165, ashley.thompson@accelclinical.com
- Recruiting
CNS Memphis
Memphis, Tennessee, 38119
Haley Edmonds, 901-843-1045, hedmonds@cnshealthcare.com
- Recruiting
Catalina Research Institute
Montclair, California, 91763
Rachelle Phillips, Site Director, rachelle.phillips@empathxresearch.com
- Recruiting
DelRicht - New Orleans
New Orleans, Louisiana, 70115
Anne Wright, 504-336-2667
- Recruiting
Medical Research Network
New York, New York, 10128
Matt Turzilli, (212) 595-5012, matthew.turzilli@imaresearch.com
- Recruiting
Excell Research
Oceanside, California, 92056
James Lamb, 760-758-2222, jlamb@excellresearch.com
- Recruiting
ATP Clinical Research
Orange, California, 92866
Bobby Shih, Site Manager, 949-354-5353, bshih@atpcr.com
Careline Lunter, Recruitment Coordinator, 949-354-5353, caralinel@pnsoc.com
- Recruiting
Inner Space Research
Orem, Utah, 84058
Inner Space Research, 801-871-5516, apply@innerspaceresearch.com
- Recruiting
CNS Healthcare
Orlando, Florida, 32801
Ashley Westerfeld, awesterfeld@cnshealthcare.com
- Recruiting
Mountain Clinical Trials LLC
Phoenix, Arizona, 85050
Anna Crossland, 602-767-2612, Annamaria@MountainClinicalTrials.com
- Recruiting
Headlands Research - Pharmasite
Pikesville, Maryland, 21208
Surya Korn, 410-497-8915, surya.korn@pharmasiteresearch.com
- Recruiting
Flourish Research
Plymouth Meeting, Pennsylvania, 19462
Landon Este, 610-277-8073
- Recruiting
Global Medical Institutes
Princeton, New Jersey, 08540
Thibaud Belleface, Recruitment Specialist, 609-921-3555, tbelleface@gminstitutes.com
- Recruiting
Midwest Research Group
Saint Charles, Missouri, 63304
Lindsay Van Winkle, 636-496-8032 ext. 5, lvanwinkle@midwestresearchgroup.com
- Recruiting
Inland Psychiatric Medical Group
San Juan Capistrano, California, 92675
Vanessa Montanez, 909-955-5865, vanessa.montanez@inlandpsych.com
- Recruiting
Seattle Neuropsychiatric Treatment Center (NTC)
Seattle, Washington, 98104
Seattle NTC Research Team, 206-467-6300 ext. 5, empower@seattlentc.com
- Recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
Jessica Sutton, 732-244-2299, jessica@bbhnj.com
- Recruiting
Del Sol Research
Tucson, Arizona, 85715
Wendy Hotz, President, R. Ph., (520) 481-8464, whotz@delsolresearch.com
- Recruiting
Suburban Research Associates
West Chester, Pennsylvania, 19380
Head of Site Operations, 601-891-9024, info@suburbanresearch.com
- Recruiting
Vitalix Clinical
Worcester, Massachusetts, 01608
Rajvi Patel, 508-723-3730, rpatel@vitalixclinical.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-1, 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 posted6 Mar 2026
- Study start2 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- NCT07456696
- Sponsor's protocol ID
- TSND201-PTSD-301
- Acronym
- EMPOWER-1
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Sep 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
- NCT07456696
- Acronym / sponsor ID
- EMPOWER-1 / TSND201-PTSD-301
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, EMPOWER-1, 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
- 2 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Mar 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 the 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) <18 kg/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 17 Sep 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.
37 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 37 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 17 Sep 2026.