Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141876
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-08
Brief Title:
Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
Sponsor:
Apex Labs Ltd
Organization:
Apex Labs Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder PTSD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
SUMMIT-90
Brief Summary:
Post-Traumatic Stress Disorder PTSD is a mental disorder that may develop in people who have been exposed to a traumatic event including actual or threatened death serious injury or sexual violence Exposure to a traumatic event is defined as directly experiencing the event learning about the event or repeated exposure to details of the event PTSD is often accompanied by other psychiatric and physical comorbidities both of which are associated with elevated healthcare costs Depression psychosis and suicide rates are consistently reported in greater proportion of PTSD patients Despite the overwhelming impact of PTSD and comorbid depression there is a shortfall of effective treatments with few side effects that target the broad range of symptoms including depression
Psilocybin has been studied for the treatment of depression anxiety tobacco and alcohol use disorders obsessive-compulsive disorder end of life depression and anxiety demonstrating safety and efficacy for a variety of indications with no significant adverse events occurring during the course of treatment and follow-up Notably in a participant group distinguished by long-standing moderate to severe major depressive disorder two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram a commonly used SSRI Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression
Based on previous research psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD Unlike traditional SSRIs which are associated with treatment-resistance and addiction psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence Furthermore the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions
Psilocybin has been studied for the treatment of depression anxiety tobacco and alcohol use disorders obsessive-compulsive disorder end of life depression and anxiety demonstrating safety and efficacy for a variety of indications with no significant adverse events occurring during the course of treatment and follow-up Notably in a participant group distinguished by long-standing moderate to severe major depressive disorder two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram a commonly used SSRI Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression
Based on previous research psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD Unlike traditional SSRIs which are associated with treatment-resistance and addiction psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence Furthermore the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions
Detailed Description:
None
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