Post Traumatic Stress DisorderPhase 2IMPACT-EXTNCT06237426
An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
A Phase 2 study testing Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 9 sites in 3 countries.
Trial summary
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD. Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Methylone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 6 Mar 2024to 6 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
- Agree to not participate in any other interventional clinical trials for the duration of this study.
- Willing and able to provide informed consent.
Who cannot join
- Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- Change or development of any physical or psychological finding that would make participant unsuitable for study.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United Kingdom5 sites
Mirabilis Health
Belfast, Northern Ireland
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge, England
NHS Greater Glasgow and Clyde
Glasgow, Scotland
Clerkenwell Health
London
Kings College
London
United States3 sites
Mountain View Clinical Research
Denver, Colorado, 80209
Cedar Clinical Research, Inc
Draper, Utah, 84020
Sunstone Medical
Rockville, Maryland, 20850
About this study
Official title: A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Methylone
- Keywords
- PTSD, IMPACT-EXT, Methylone, Neuroplastogen, Transcend Therapeutics, TSND-201
- 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
A course of treatment includes 4 weekly doses of TSND-201.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Methylone) | Experimental | Not described Receives: Drug: Methylone |
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
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
Measured: Up to 52 weeks
Secondary outcomes (1)
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Types and rates of adverse events
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start6 Mar 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT06237426
- Sponsor's protocol ID
- TSND201-PTSD-203
- Acronym
- IMPACT-EXT
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2024
- Last updated
- 25 Nov 2025
- Results posted
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments With Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
- ClinicalTrials.gov ID
- NCT06237426
- Acronym / sponsor ID
- IMPACT-EXT / TSND201-PTSD-203
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, IMPACT-EXT, Methylone, Neuroplastogen, Transcend Therapeutics, TSND-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 1 Feb 2024 (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 is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.
Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.
Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Methylone) | Experimental | Drug: Methylone |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
- Agree to not participate in any other interventional clinical trials for the duration of this study.
- Willing and able to provide informed consent.
Key exclusion criteria (2 listed)
- Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
- Change or development of any physical or psychological finding that would make participant unsuitable for study.
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 |
|---|---|---|
| MethyloneA course of treatment includes 4 weekly doses of TSND-201. | Drug | Treatment (Methylone) |
Primary outcome
Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
Time frame: Up to 52 weeks
The CAPS-5 is a structured interview designed to assess PTSD symptom severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.
1 secondary outcome
Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- 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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylone in people with Post Traumatic Stress Disorder, run by Transcend Therapeutics at 9 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 3 inclusion and 2 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 25 Nov 2025. 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 Kingdom, United States, 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (time frame: Up to 52 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 25 Nov 2025.