Trial Outcomes & Findings for A Study to Assess the Use of Methylone in the Treatment of PTSD (NCT NCT05741710)

Last Updated: 2026-04-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

79 participants

Primary outcome timeframe

up to 10 weeks

Results posted on

2026-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Open-label TSND-201 (Part A) Open-label TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks.	Blinded TSND-201 (Part B) Blinded TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks	Blinded Placebo (Part B) Blinded placebo to match TSND-201.
Overall Study COMPLETED	13	30	29
Overall Study NOT COMPLETED	1	2	4
Overall Study STARTED	14	32	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Use of Methylone in the Treatment of PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label TSND-201 (Part A) n=14 Participants Open-label TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks.	Blinded TSND-201 (Part B) n=32 Participants Blinded TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks	Blinded Placebo (Part B) n=33 Participants Blinded placebo to match TSND-201.	Total n=79 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=193 Participants	2 Participants n=193 Participants	0 Participants n=386 Participants	2 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=193 Participants	0 Participants n=193 Participants	1 Participants n=386 Participants	2 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=193 Participants	0 Participants n=193 Participants	2 Participants n=386 Participants	3 Participants n=13 Participants
Age, Continuous	42.4 Years STANDARD_DEVIATION 11.44 • n=193 Participants	45.1 Years STANDARD_DEVIATION 10.60 • n=193 Participants	42.2 Years STANDARD_DEVIATION 10.34 • n=386 Participants	43.1 Years STANDARD_DEVIATION 10.9 • n=13 Participants
Sex: Female, Male Female	10 Participants n=193 Participants	19 Participants n=193 Participants	20 Participants n=386 Participants	49 Participants n=13 Participants
Sex: Female, Male Male	4 Participants n=193 Participants	13 Participants n=193 Participants	13 Participants n=386 Participants	30 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=193 Participants	1 Participants n=193 Participants	1 Participants n=386 Participants	2 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	0 Participants n=193 Participants	0 Participants n=193 Participants	2 Participants n=386 Participants	2 Participants n=13 Participants
Race (NIH/OMB) White	13 Participants n=193 Participants	29 Participants n=193 Participants	29 Participants n=386 Participants	71 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=193 Participants	26 Participants n=193 Participants	28 Participants n=386 Participants	61 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=193 Participants	6 Participants n=193 Participants	3 Participants n=386 Participants	15 Participants n=13 Participants

PRIMARY outcome

Timeframe: up to 10 weeks

Population: mITT population

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.

Outcome measures

Outcome measures
Measure	Open-label TSND-201 (Part A) n=13 Participants Open-label TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks.	Blinded TSND-201 (Part B) n=30 Participants Blinded TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks	Blinded Placebo (Part B) n=30 Participants Blinded placebo to match TSND-201.
Change From Baseline in CAPS-5 Total Severity Score	-36.2 points Standard Error 3.87	-23.3 points Standard Error 2.84	-13.6 points Standard Error 2.95

Adverse Events

All TSND-201 (Part A & B)

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo (Part B)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All TSND-201 (Part A & B) n=46 participants at risk TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks.	Placebo (Part B) n=33 participants at risk Blinded placebo to match TSND-201.
Nervous system disorders Seizure	2.2% 1/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.

Other adverse events

Additional Information

Amanda Jones

Transcend Therapeutics

Phone: 9199238150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	All TSND-201 (Part A & B) n=46 participants at risk TSND-201: 150mg, followed by 100mg, 90minutes later. Given once a week for 4 weeks.	Placebo (Part B) n=33 participants at risk Blinded placebo to match TSND-201.
Psychiatric disorders Anxiety	13.0% 6/46 • From enrollment until end of follow-up, up to 10 weeks.	6.1% 2/33 • From enrollment until end of follow-up, up to 10 weeks.
General disorders Non-cardiac chest pain	10.9% 5/46 • From enrollment until end of follow-up, up to 10 weeks.	6.1% 2/33 • From enrollment until end of follow-up, up to 10 weeks.
Renal and urinary disorders Urine flow decreased	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Psychiatric disorders Emotional distress	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	3.0% 1/33 • From enrollment until end of follow-up, up to 10 weeks.
Eye disorders Vision blurred	10.9% 5/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
General disorders Pre-existing condition improved	17.4% 8/46 • From enrollment until end of follow-up, up to 10 weeks.	6.1% 2/33 • From enrollment until end of follow-up, up to 10 weeks.
Nervous system disorders Paraesthesia	13.0% 6/46 • From enrollment until end of follow-up, up to 10 weeks.	9.1% 3/33 • From enrollment until end of follow-up, up to 10 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	17.4% 8/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Renal and urinary disorders Dysuria	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	3.0% 1/33 • From enrollment until end of follow-up, up to 10 weeks.
Investigations Heart rate increased	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Psychiatric disorders Logorrhea	10.9% 5/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Cardiac disorders Palpitation	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	15.2% 5/33 • From enrollment until end of follow-up, up to 10 weeks.
Nervous system disorders Tremor	13.0% 6/46 • From enrollment until end of follow-up, up to 10 weeks.	3.0% 1/33 • From enrollment until end of follow-up, up to 10 weeks.
Nervous system disorders Headache	58.7% 27/46 • From enrollment until end of follow-up, up to 10 weeks.	42.4% 14/33 • From enrollment until end of follow-up, up to 10 weeks.
Metabolism and nutrition disorders Decreased appetite	43.5% 20/46 • From enrollment until end of follow-up, up to 10 weeks.	9.1% 3/33 • From enrollment until end of follow-up, up to 10 weeks.
Investigations Blood pressure increased	26.1% 12/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Gastrointestinal disorders Dry mouth	23.9% 11/46 • From enrollment until end of follow-up, up to 10 weeks.	3.0% 1/33 • From enrollment until end of follow-up, up to 10 weeks.
Gastrointestinal disorders Nausea	28.3% 13/46 • From enrollment until end of follow-up, up to 10 weeks.	21.2% 7/33 • From enrollment until end of follow-up, up to 10 weeks.
Nervous system disorders Dizziness	28.3% 13/46 • From enrollment until end of follow-up, up to 10 weeks.	9.1% 3/33 • From enrollment until end of follow-up, up to 10 weeks.
Psychiatric disorders Insomnia	28.3% 13/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
General disorders Fatigue	19.6% 9/46 • From enrollment until end of follow-up, up to 10 weeks.	12.1% 4/33 • From enrollment until end of follow-up, up to 10 weeks.
Psychiatric disorders Bruxism	17.4% 8/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
Musculoskeletal and connective tissue disorders Muscle tightness	17.4% 8/46 • From enrollment until end of follow-up, up to 10 weeks.	3.0% 1/33 • From enrollment until end of follow-up, up to 10 weeks.
General disorders Feeling of relaxation	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	18.2% 6/33 • From enrollment until end of follow-up, up to 10 weeks.
Cardiac disorders Tachycardia	8.7% 4/46 • From enrollment until end of follow-up, up to 10 weeks.	0.00% 0/33 • From enrollment until end of follow-up, up to 10 weeks.
General disorders Feeling abnormal	15.2% 7/46 • From enrollment until end of follow-up, up to 10 weeks.	9.1% 3/33 • From enrollment until end of follow-up, up to 10 weeks.