Post Traumatic Stress DisorderPhase 1/2IMPACT-1NCT05741710
A Study to Assess the Use of Methylone in the Treatment of PTSD
A Phase 1/2 study testing Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 16 sites in 3 countries.
Trial summary
This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts. Part A is open-label and will enroll up to 15 participants with PTSD Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Methylone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 1 Mar 2023to 19 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
- CAPS-5 score of ≥35 at Screening.
- Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- Proficient in reading and writing in local language sufficient to complete 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.
- Smokes an average of >10 cigarettes and/or e-cigarettes per day
- Uncontrolled hypertension at Screening
- Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
- Use of an SSRI or other antidepressant within 8 weeks of screening.
- Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States8 sites
Cenexel HRI
Berlin, New Jersey, 08009
Boston Clinical Trials
Boston, Massachusetts, 02131
Mountain View Clinical Research
Denver, Colorado, 80209
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
Accel Research Sites
Maitland, Florida, 32751
Cedar Clinical Research
Murray, Utah, 84107
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112
Sunstone Therapies
Rockville, Maryland, 20850
United Kingdom6 sites
Mirabilis Health
Belfast, Northern Ireland
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Glasgow Clinical Research Facility, QEUH
Glasgow
Clerkenwell Health
London
King's College
London
Oxford Health NHS Foundation Trust
Oxford
Ireland2 sites
Tallaght Adult Mental Health Services
Dublin
La Nua Day Hospital Mental Health Centre
Galway
About this study
Official title: A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD
Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Methylone, Placebo
- Keywords
- methylone, PTSD, IMPACT-1, Transcend Therapeutics
- 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.
MethyloneDrug
Methylone capsules, given orally, once a week for 4 weeks
PlaceboDrug
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
| Study group | Role | What they receive |
|---|---|---|
| Methylone | Experimental | Not described Receives: Drug: Methylone |
| 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 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 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Mar 2023
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741710
- Sponsor's protocol ID
- TT-TSND-201
- Acronym
- IMPACT-1
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2023
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones A, Warner-Schmidt J, Kwak H, Stogniew M, Mandell B, Ching THW, Stein MB, Kelmendi B. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial. JAMA Psychiatry. 2026 May 1;83(5):469-477. doi: 10.1001/jamapsychiatry.2025.4625.
PubMed 41706459
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
- ClinicalTrials.gov ID
- NCT05741710
- Acronym / sponsor ID
- IMPACT-1 / TT-TSND-201
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- methylone, PTSD, IMPACT-1, Transcend Therapeutics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Posted 15 Apr 2026
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, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD
Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylone | Experimental | Drug: Methylone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
- CAPS-5 score of ≥35 at Screening.
- Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- Proficient in reading and writing in local language sufficient to complete questionnaires.
- Free from any other clinically significant illness or disease
Key exclusion criteria (7 listed)
- Primary diagnosis of any other DSM-5 disorder
- Body mass index (BMI) <18 kg/m2 or ≥40 kg/m2.
- Smokes an average of >10 cigarettes and/or e-cigarettes per day
- Uncontrolled hypertension at Screening
- Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
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 |
|---|---|---|
| MethyloneMethylone capsules, given orally, once a week for 4 weeks | Drug | Methylone |
| PlaceboPlacebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B | Drug | Placebo |
Primary outcome
Change From Baseline in CAPS-5 Total Severity Score
Time frame: up to 10 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41706459Jones A, Warner-Schmidt J, Kwak H, Stogniew M, Mandell B, Ching THW, Stein MB, Kelmendi B. Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD: A Randomized Clinical Trial. JAMA Psychiatry. 2026 May 1;83(5):469-477. doi: 10.1001/jamapsychiatry.2025.4625.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 16 sites in 3 countries.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, United Kingdom, Ireland. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in CAPS-5 Total Severity Score (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741710, which also lists 1 linked publication.
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 15 Apr 2026.