Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353938
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-07-17
Brief Title:
Study of 34-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder
Sponsor:
Lykos Therapeutics
Organization:
Lykos Therapeutics
Study Overview
Official Title:
Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 34-methylenedioxymethamphetamine MDMAAssisted Psychotherapy in Posttraumatic Stress Disorder PTSD- Switzerland
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:
None
Brief Summary:
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD with PTSD symptoms not improving after trying at least one treatment This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy scheduled three to five weeks apart can be safely administered to participants with PTSD and whether combining a fully therapeutic dose of MDMA with psychotherapy when compared with a low active placebo dose of MDMA will reduce PTSD symptoms Participants will be randomly assigned to receive the full dose of MDMA 125 mg or assigned to receive a low or active placebo dose of MDMA 25 mg during each of three experimental sessions
Detailed Description:
Posttraumatic stress disorder PTSD occurs after experiencing a traumatic event or events PTSD is a public health problem that causes a great deal of suffering
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD with PTSD symptoms not improving after trying at least one treatment This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy scheduled three to five weeks apart can be safely administered to participants with PTSD and whether combining a fully therapeutic dose of MDMA with psychotherapy when compared with a low active placebo dose of MDMA will reduce PTSD symptoms Participants will be randomly assigned to receive the full dose of MDMA 125 mg or assigned to receive a low or active placebo dose of MDMA 25 mg during each of three experimental sessions
People who receive the low dose of MDMA have the opportunity to take part in a second open label study continuation wherein the participants will undergo three MDMA-assisted sessions with the participant and the researchers knowing that a full dose of MDMA is being administered People who receive the full dose of MDMA and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD with PTSD symptoms not improving after trying at least one treatment This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy scheduled three to five weeks apart can be safely administered to participants with PTSD and whether combining a fully therapeutic dose of MDMA with psychotherapy when compared with a low active placebo dose of MDMA will reduce PTSD symptoms Participants will be randomly assigned to receive the full dose of MDMA 125 mg or assigned to receive a low or active placebo dose of MDMA 25 mg during each of three experimental sessions
People who receive the low dose of MDMA have the opportunity to take part in a second open label study continuation wherein the participants will undergo three MDMA-assisted sessions with the participant and the researchers knowing that a full dose of MDMA is being administered People who receive the full dose of MDMA and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None