Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Lead sponsor: HaEmek Medical Center, Israel to Guy Schusheim Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Study completion moved earlier from Dec 1, 2028 to Jul 1, 2028
    • Trial arms changed: 0 → 2
    • Eligibility criteria shortened, about 99 words
    • Secondary endpoints expanded, about 43 words
    • Study description shortened, about 167 words
    • Collaborator revised
    • Study title shortened, about 4 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 1, 2024 to Jun 1, 2027
    • Study sites: 0 to 1
    • Study completion date: Dec 1, 2024 to Dec 1, 2028
    • Study description expanded, about 57 words
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Guy Schusheim
1 trial monitored
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PTSD
895 trials monitored
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The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol. The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .
Trial Details
NCT Number NCT05732155
Lead Sponsor Guy Schusheim
Collaborators: Resilient Pharmaceuticals
Conditions
(from sponsor)		 Post Traumatic Stress Disorder, MDMA ('Ecstasy')
Related terms Stress Disorders, Post-Traumatic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov