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NCT05790239 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Stephen Robert Marder.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT05790239: Recruiting Phase 2 study of Post Traumatic Stress Disorder, sponsored by Stephen Robert Marder.
NCT05790239 is a Phase 2 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Stephen Robert Marder. The registered enrollment target is 40 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05790239, a Phase 2 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Stephen Robert Marder.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.
Primary Outcome
The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to Visit 17, assessed by a blinded study staff rater. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Conditions Studied
Interventions
- DRUG d-amphetamine
- DRUG 3,4-methylenedioxymethamphetamine
- BEHAVIORAL Therapy
Study Locations (2)
California
- VA Greater Los Angeles Healthcare System, Westwood campus - Los Angeles
- West Los Angeles Veteran Affairs - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What NCT05790239 shows while recruiting
NCT05790239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which d-amphetamine is the first listed.
NCT05790239 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05790239 about?
NCT05790239 is a clinical study titled "MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder". This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate ...
What is the current status of trial NCT05790239?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-03-01. Estimated completion is 2026-03.
What conditions does trial NCT05790239 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05790239?
The interventions under investigation include: d-amphetamine (DRUG), 3,4-methylenedioxymethamphetamine (DRUG), Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05790239?
This trial is sponsored by Stephen Robert Marder, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05790239 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05790239's enrollment target sits among peer trials
40 187th of 262 higher than 65 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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