Summary

Eligibility
for people ages 16-17 (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Jessica K Jeffrey, MD, MPH, MBA

Description

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.

Official Title

3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents

Details

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.

Keywords

PTSD, Post Traumatic Stress Disorder, Adolescents, Psychotherapy, PTSD, MDMA, Adolescent, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, MDMA Psychotherapy

Eligibility

Location

  • UCLA Semel Institute for Neuroscience and Human Behavior
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Jessica K Jeffrey, MD, MPH, MBA
    HS Associate Clinical Professor, Psychiatry and Biobehavioral Sciences, Medicine. Authored (or co-authored) 17 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06353282
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated