A Phase 1/2 interventional study of Methylone and Placebo in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Completed at 16 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Transcend Therapeutics (part of Otsuka Holdings Co., Ltd.) · Phase 1/2, Interventional, and Treatment
This study is evaluating the safety, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 79 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Transcend Therapeutics is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
First submitted before Transcend Therapeutics became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylone
Drug: Placebo
Methylone capsules, given orally, once a week for 4 weeks
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
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.
Time frame: up to 10 weeks
| Milestone | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) |
|---|---|---|---|
| Started | 14 | 32 | 33 |
| Completed | 13 | 30 | 29 |
| Not completed | 1 | 2 | 4 |
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.
| points | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) |
|---|---|---|---|
| Change From Baseline in CAPS-5 Total Severity Score | -36.2 ± 3.87 | -23.3 ± 2.84 | -13.6 ± 2.95 |
Collected over From enrollment until end of follow-up, up to 10 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All TSND-201 (Part A & B) | 0/46 (0%) | 1/46 (2.2%) | 43/46 (93.5%) |
| Placebo (Part B) | 0/33 (0%) | 0/33 (0%) | 24/33 (72.7%) |
| Event | All TSND-201 (Part A & B) | Placebo (Part B) |
|---|---|---|
| SeizureNervous system disorders | 1/46 | 0/33 |
| Event | All TSND-201 (Part A & B) | Placebo (Part B) |
|---|---|---|
| HeadacheNervous system disorders | 27/46 | 14/33 |
| Decreased appetiteMetabolism and nutrition disorders | 20/46 | 3/33 |
| NauseaGastrointestinal disorders | 13/46 | 7/33 |
| DizzinessNervous system disorders | 13/46 | 3/33 |
| InsomniaPsychiatric disorders | 13/46 | 0/33 |
| Blood pressure increasedInvestigations | 12/46 | 0/33 |
| Dry mouthGastrointestinal disorders | 11/46 | 1/33 |
| FatigueGeneral disorders | 9/46 | 4/33 |
| Feeling of relaxationGeneral disorders | 4/46 | 6/33 |
| BruxismPsychiatric disorders | 8/46 | 0/33 |
| Age, Continuous(Years) | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) | Total |
|---|---|---|---|---|
| Mean | 42.4 ± 11.44 | 45.1 ± 10.60 | 42.2 ± 10.34 | 43.1 ± 10.9 |
| Sex: Female, Male(Participants) | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) | Total |
|---|---|---|---|---|
| Female | 10 | 19 | 20 | 49 |
| Male | 4 | 13 | 13 | 30 |
| Race (NIH/OMB)(Participants) | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 2 | 2 |
| White | 13 | 29 | 29 | 71 |
| More than one race | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Open-label TSND-201 (Part A) | Blinded TSND-201 (Part B) | Blinded Placebo (Part B) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 3 |
| Not Hispanic or Latino | 7 | 26 | 28 | 61 |
| Unknown or Not Reported | 6 | 6 | 3 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylone
Stress Disorders, Post-Traumatic →