MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Status Not yet recruiting

Clinical Trial Summary

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Clinical Trial Description

This study is an open-label fixed dose trial whereby youth with treatment-resistant post-traumatic stress disorder (PTSD) will be recruited. Treatment-resistant depression is defined as having continued Diagnostic Statistical Manual (DSM-5) diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months of SSRI pharmacotherapy. Before entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06353282
Study type	Interventional
Source	University of California, Los Angeles
Contact	Jessica K Jeffrey, MD, MPH, MBA
Phone	310-825-5263
Email	jjeffrey@mednet.ucla.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	July 1, 2025
Completion date	December 31, 2026

View Details

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