Post Traumatic Stress DisorderPhase 2IMPACT-2NCT06215261
An Evaluation of the Safety and Efficacy 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 12 sites in 3 countries.
Trial summary
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. Part A is open-label and will enroll up to 15 participants with PTSD Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD Eligible participants will enter a… Read more about this study
- Who is it for?
- Ages 18 to 70 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?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 4 Apr 2024to 23 Sep 2025
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
- Tried 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) <18kg/m2 or ≥40 kg/m2.
- Smokes an average of >10 cigarettes and/or e-cigarettes per day.
- Uncontrolled hypertension at Screening.
- Use of prohibited concomitant medications or therapies.
- Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States8 sites
Seattle NTC
Bellevue, Washington, 98004
Uptown Clinical Research
Chicago, Illinois, 60640
Numinus
Draper, Utah, 84020
Redbird Research LLC
Las Vegas, Nevada, 89119
Segal Trials
Lauderhill, Florida, 33319
Accel Research
Maitland, Florida, 32751
CNS Healthcare
Orlando, Florida, 32801
Sunstone Medical
Rockville, Maryland, 20850
Australia3 sites
Swinburne University of Technology
Hawthorn, Victoria, 3122
Ramsay Clinic Albert Road
Melbourne, Victoria, 3004
Monarch Mental Health Group
Melbourne, Victoria
About this study
Official title: An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD
Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Methylone
- Keywords
- Methylone, IMPACT-2, PTSD, Neuroplastogen, 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
Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)
| Study group | Role | What they receive |
|---|---|---|
| TSND-201 Low Dose | Experimental | Part B only Receives: Drug: Methylone |
| TSND-201 Mid Dose | Experimental | Part B only Receives: Drug: Methylone |
| TSND-201 High Dose | Experimental | Part B only 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 the 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: 9 weeks (Part A) / 12 weeks (Part B)
Secondary outcomes (4)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item, clinician-rated scale designed to assess severity of depression. The total score ranges from 0 to 60, with a higher score indicating more severe depression.
Measured: 9 weeks (Part A) / 12 weeks (Part B)
Change From Baseline in PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item, patient-rated scale designed to measure severity of PTSD symptoms. The total score ranges from 0 to 80, with a higher score indicating more severe PTSD symptoms.
Measured: 9 weeks (Part A) / 12 weeks (Part B)
Change From Baseline in Sheehan Disability Scale (SDS)
The SDS is a 3-item, patient-rated scale designed to measure disability and impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is scored from 0 to 10, with higher scores representing greater disability. Total scores range from 0 to 30, with higher scores representing greater disability.
Measured: 9 weeks (Part A) / 12 weeks (Part B)
Incidence of Treatment-emergent Adverse Events (TEAEs)
Types and rates of adverse events (Results are presented in the Adverse Events section)
Measured: 9 weeks (Part A) / 12 weeks (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start4 Apr 2024
- Primary completion23 Sep 2025
- Study completion23 Sep 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT06215261
- Sponsor's protocol ID
- TSND201-PTSD-202
- Acronym
- IMPACT-2
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2024
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
- ClinicalTrials.gov ID
- NCT06215261
- Acronym / sponsor ID
- IMPACT-2 / TSND201-PTSD-202
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Methylone, IMPACT-2, PTSD, Neuroplastogen, TSND-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Transcend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 30 Oct 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 and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
- Part A is open-label and will enroll up to 15 participants with PTSD
- Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD
Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TSND-201 Low Dose | Experimental | Drug: MethylonePart B only |
| TSND-201 Mid Dose | Experimental | Drug: MethylonePart B only |
| TSND-201 High Dose | Experimental | Drug: MethylonePart B only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
- Tried 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 (6 listed)
- Primary diagnosis of any other DSM-5 disorder.
- Body mass index (BMI) <18kg/m2 or ≥40 kg/m2.
- Smokes an average of >10 cigarettes and/or e-cigarettes per day.
- Uncontrolled hypertension at Screening.
- Use of prohibited concomitant medications or therapies.
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 3 weeks (Part A) or 4 weeks (Part B) | Drug | TSND-201 High Dose, TSND-201 Low Dose, TSND-201 Mid Dose |
Primary outcome
Change From Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) Total Severity Score
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
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.
4 secondary outcomes
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
Change From Baseline in PTSD Checklist for DSM-5 (PCL-5)
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
Change From Baseline in Sheehan Disability Scale (SDS)
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
12 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 12 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 4 inclusion and 6 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 30 Oct 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 Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) Total Severity Score (time frame: 9 weeks (Part A) / 12 weeks (Part B)). 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 30 Oct 2026.