Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353282
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-25
Brief Title:
MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
3 4-methylenedioxymethamphetamine MDMA for Treatment-resistant Post-traumatic Stress Disorder PTSD in Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the safety and feasibility of 34-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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None