This study is a Phase 2, randomized, double-blind, active-controlled, two-arm, single-site clinical trial designed to evaluate the safety, tolerability, and feasibility of MDMA-Assisted Therapy (MDMA-AT) for Service Members (Active Duty, Guard, or Reserve) diagnosed with moderate-to-severe Post-Traumatic Stress Disorder (PTSD) within a Military Health System (MHS) setting.
The trial incorporates Acceptance and Commitment Therapy (ACT) as a core therapeutic modality. Participants will receive MDMA-AT utilizing either full-dose or active-control low-dose MDMA. The trial will also assess a regional referral center model by recruiting participants locally from the National Capital Region and non-locally across the MHS.
Positive endorsement of at least 1 index trauma on the LEC-5.
Have a PCL-5 total score of 38 or greater at screening.
Meet DSM-5-TR criteria for current PTSD per Mini International Neuropsychiatric Interview (MINI) at screening with a symptom duration of 6 months or longer.
Meet criteria for PTSD diagnosis per CAPS-5-R with a score of 26 or greater.
History of or current primary psychotic disorder to include Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder 1 assessed via MINI or clinical evaluation.
Current Major Depressive Disorder with Psychotic Features assessed via MINI or clinical evaluation.
Current eating disorder with active purging assessed via MINI or clinical evaluation.
Current Borderline Personality Disorder assessed via SCID-5-PD or clinical evaluation.
Parallel
TREATMENT ARM: Full dose
DrugParticipants in this arm will receive full dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)
CONTROL ARM: Active-controlled
DrugParticipants in this arm will receive lower dose of MDMA integrated with Acceptance and Commitment Therapy (ACT)
Change in Revised Clinician Administered PTSD Scale for DSM-5 (CAPS-5-R) Total Severity Score From Baseline to Primary Outcome
The primary objective of this study is to determine treatment efficacy of MDMA-AT for PTSD by comparing PTSD symptom severity as measured by independent raters with the CAPS-5-R \[Revised Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)\] as measured from baseline to the primary endpoint which is 1 month after the third dosing session. The CAPS-5-R is a structured clinician-administered measure that assesses the presence and severity of PTSD per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. All the DSM-5 symptoms of PTSD are assessed and rated on a scale from 0 (Absent) to 10 (Extremely Severe), with clear anchors provided to clinicians to assist with accurate ratings. The range of the scale is 0-200.The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
Change in Revised Clinician-Administered PTSD Scale for DSM-5 (CAPS-5-R) Total Severity Score From Primary Endpoint to Secondary Endpoint
Determine durability of treatment efficacy by comparing changes in PTSD symptom severity (Revised Clinician-Administered PTSD Scale for DSM-5 \[CAPS-5-R\]), from primary endpoint to final outcome (secondary endpoint). The CAPS-5-R is a structured clinician-administered measure that assesses the presence and severity of PTSD per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. All the DSM-5 symptoms of PTSD are assessed and rated on a scale from 0 (Absent) to 10 (Extremely Severe), with clear anchors provided to clinicians to assist with accurate ratings. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from primary to secondary endpoint the better the outcome.
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U.S. Army Medical Research and Development Command
Lead sponsor
Resilient Pharmaceuticals
Collaborator
Walter Reed National Military Medical Center
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
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