High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder: An Open-Label Pilot Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508229-28-00

Enrollment

Registered

2024-04-18

Start date

2025-05-16

Completion date

Unknown

Last updated

2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

posttraumatic stress disorder

Brief summary

Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 12 weeks post Baseline (Visit 23).

Detailed description

Mean change in Sheehan Disability Scale (SDS) scores from Visit 4 (Baseline) to Visit 23 (12 weeks post Baseline)., Number, percentage and reasons for Screen Failure and Dropout.

Interventions

DRUG3

DRUG4-methylenedioxymethamphetamine hydrochloride

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Mean change in CAPS-5-R Total Severity Score from Baseline (Visit 4) to 12 weeks post Baseline (Visit 23).	—

Secondary

Measure	Time frame
Mean change in Sheehan Disability Scale (SDS) scores from Visit 4 (Baseline) to Visit 23 (12 weeks post Baseline)., Number, percentage and reasons for Screen Failure and Dropout.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026