Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05066282
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2021-09-23
Brief Title:
Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPLONG
Brief Summary:
Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder PTSD independent of cause is treatable with up to three sessions of MDMA-assisted therapy This non-interventional study will serve as the long-term follow-up LTFU protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the Clinician-Administered PTSD Scale for DSM-5 CAPS-5 as a measure of PTSD symptom severity Additionally this study will gather data to support health economics and cost effectiveness analyses of this treatment Participants who have received at least one dose of Investigational Medicinal Product IMP in the main study will be eligible to participate in this study
Detailed Description:
The Multidisciplinary Association for Psychedelic Studies MAPS is a non-profit research and education organization working as a clinical trial sponsor to obtain approval for the prescription use of 34-methylenedioxymethamphetamine MDMA as an adjunct to therapy for treatment of posttraumatic stress disorder PTSD Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic PTSD independent of cause is treatable with up to three sessions of MDMA-assisted therapy This non-interventional study will serve as the long-term follow-up LTFU protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the CAPS-5 as a measure of PTSD symptom severity The primary objective of this study is to evaluate the long-term effectiveness of MDMA-assisted therapy for treatment of PTSD as measured by the change in CAPS-5 Total Severity Score actual or imputed from the main study Baseline and Study Termination to LTFU IR Assessments Visit 1 Additionally this study will gather data to support health economics and cost effectiveness analyses of this treatment Participants who have received at least one dose of Investigational Medicinal Product IMP in the main study will be eligible to participate in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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