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MDMA

Phase 2

Post-Traumatic Stress Disorder | Small molecule | Psychiatry |Nautilus Biotechnology, Inc.|Last Updated: May 5, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical trial landscape

MDMA · 1 trial · 2 indications

Phase 2 1
NCT05455996MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First RespondersPost-Traumatic Stress Disorder
NOT YET_RECRUITING30 Analytics
PHASE2NOT YET_RECRUITING
MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers and First Responders
Post-Traumatic Stress Disorder
NCT0545599630
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Study Endpoints
Primary Endpoints
Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination
Up to 17 weeks post-enrollment (Baseline)

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD and is widely used by researchers and clinicians to monitor change during and after a treatment intervention. Participants indicate how much distress they have experienced due to symptoms such as "Repeated, disturbing memories, thoughts, or images of a stressful experience from the past," "Trouble remembering important parts of a stressful experience from the past," and "Feeling irritable or having angry outbursts" using a Likert scale ranging from 0 (Not at all) to 4 (Extremely). Items are summed to provide a total severity score (range = 0-80). It takes 5-10 minutes to complete.

Secondary Endpoints
Change from Baseline on symptoms of Adjustment Disorder based on the Adjustment Disorder New Module-20 (ADNM-20) at Treatment Termination
Up to 17 weeks post-enrollment (Baseline)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MDMA-assisted therapyEXPERIMENTALParticipants will receive 3-dosing model of MDMA-assisted therapy (includes 9 non-drug therapy sessions)
Interventions
NameTypeDescription
MDMADRUGMDMA-assisted therapy
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Were exposed to stressors related to their work in a health care setting or emergency response system * Are fluent in speaking and reading English. * Are able to swallow pills. * Agree to have study visits recorded, including Experimental Sessions, and non-drug therapy session...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05455996primaryCompletionDate: changed
LOWMay 24, 2026NCT05455996studyFirstPostDate: changed