A Phase 2 interventional study of Methylone in Post Traumatic Stress Disorder, sponsored by Transcend Therapeutics. Completed at 12 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Transcend Therapeutics (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
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).
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 62 is below 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.
Part B only
Drug: Methylone
Part B only
Drug: Methylone
Part B only
Drug: Methylone
Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)
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.
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 9 weeks (Part A) / 12 weeks (Part B)
| Milestone | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| Started | 15 | 17 | 15 | 15 |
| Completed | 15 | 14 | 13 | 14 |
| Not completed | 0 | 3 | 2 | 1 |
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.
| score on a scale | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| Change From Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) Total Severity Score | -24.9 ± 9.74 | -26.7 ± 17.68 | -26.5 ± 10.89 | -32.9 ± 11.73 |
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.
| score on a scale | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -15.3 ± 10.61 | -15.2 ± 13.33 | -14.3 ± 10.33 | -22.9 ± 10.38 |
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.
| score on a scale | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| Change From Baseline in PTSD Checklist for DSM-5 (PCL-5) | -30.4 ± 14.35 | -29.1 ± 18.37 | -33.1 ± 9.81 | -39.8 ± 14.84 |
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.
| points | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| Change From Baseline in Sheehan Disability Scale (SDS) | -11.4 ± 8.32 | -12.4 ± 7.63 | -10.2 ± 9.20 | -16.2 ± 7.32 |
Types and rates of adverse events (Results are presented in the Adverse Events section)
Results for this outcome have not been posted.
Collected over From first dose to end of study, up to 9 weeks in Part A and 12 weeks in Part B. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A (150 mg Once a Week x 3) | 0/15 (0%) | 1/15 (6.7%) | 15/15 (100%) |
| Part B (50 mg Once a Week x 4) | 0/17 (0%) | 0/17 (0%) | 17/17 (100%) |
| Part B (100 mg Once a Week x 4) | 0/15 (0%) | 0/15 (0%) | 14/15 (93.3%) |
| Part B (150 mg Once a Week x 4) | 0/15 (0%) | 0/15 (0%) | 14/15 (93.3%) |
| Event | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| CellulitisInfections and infestations | 1/15 | 0/17 | 0/15 | 0/15 |
| Event | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 11/15 | 3/17 | 7/15 | 4/15 |
| HeadacheNervous system disorders | 6/15 | 9/17 | 7/15 | 5/15 |
| DizzinessNervous system disorders | 5/15 | 3/17 | 6/15 | 3/15 |
| FatigueGeneral disorders | 2/15 | 6/17 | 4/15 | 4/15 |
| ParaesthesiaNervous system disorders | 4/15 | 6/17 | 4/15 | 3/15 |
| Sensory disturbanceNervous system disorders | 0/15 | 1/17 | 5/15 | 2/15 |
| Feeling abnormalGeneral disorders | 1/15 | 3/17 | 1/15 | 5/15 |
| Dry mouthGastrointestinal disorders | 5/15 | 1/17 | 5/15 | 3/15 |
| Pre-existing condition improvedGeneral disorders | 0/15 | 2/17 | 3/15 | 4/15 |
| Time perception alteredPsychiatric disorders | 0/15 | 0/17 | 2/15 | 4/15 |
| Age, Continuous(Years) | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) | Total |
|---|---|---|---|---|---|
| Mean | 44.5 ± 10.23 | 44.5 ± 10.37 | 40.3 ± 12.38 | 44.0 ± 10.26 | 43.0 ± 10.94 |
| Sex: Female, Male(Participants) | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) | Total |
|---|---|---|---|---|---|
| Female | 10 | 11 | 12 | 10 | 43 |
| Male | 5 | 6 | 3 | 5 | 19 |
| Race (NIH/OMB)(Participants) | Part A (150 mg Once a Week x 3) | Part B (50 mg Once a Week x 4) | Part B (100 mg Once a Week x 4) | Part B (150 mg Once a Week x 4) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 1 | 1 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 1 | 3 | 1 | 1 | 6 |
| White | 13 | 12 | 10 | 12 | 47 |
| More than one race | 0 | 0 | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 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 →