Pardesiya

Researchers are evaluating the safety, tolerability, and effectiveness of group-based MDMA-assisted therapy compared to individual MDMA-assisted therapy in adults diagnosed with PTSD following the events of October 7, 2023. This Phase 2 clinical trial aims to determine if group-based therapy is not inferior to individual therapy regarding safety and effectiveness for treating PTSD symptoms. PTSD is a severe disorder that affects daily life and has limited effective treatment options, highlighting the need for improved therapies. MDMA is studied as an adjunct to therapy to enhance treatment outcomes, not used alone as a medication. Participants are randomly assigned to receive either group-based or individual MDMA-assisted therapy, where MDMA HCl is given orally in divided doses during three dosing sessions. The first session includes an 80 mg dose followed by a 40 mg supplemental dose 1.5 to 2 hours later, and the second and third sessions include a 120 mg dose followed by a 60 mg supplemental dose. Before dosing, participants attend preparatory therapy sessions, and after dosing, integration sessions occur. Throughout dosing, vital signs are monitored by medical staff, and safety procedures include physical exams, ECGs, urine drug tests, and laboratory tests. Participants undergo pre-screening and detailed screening including medical and psychiatric history, medication review, and questionnaires assessing PTSD symptoms. They complete questionnaires at multiple study visits to track symptoms and other measures. Safety monitoring includes adverse event tracking and suicidality assessments (C-SSRS), with oversight by an external Data Safety Monitoring Board. The main outcomes measured are changes in PTSD symptoms from baseline to the end of treatment, measured by CAPS-5 and PCL-5 scales. The study lasts up to 17 weeks depending on the treatment arm, including therapy and monitoring visits.