Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341426
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-04
Brief Title:
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression Comparing One Versus Two Doses of Psilocybin
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin PSI-1V2
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PSI-1V2
Brief Summary:
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression TRD Researchers also want to know if a second dose of psilocybin is safe and well-tolerated This study will see if psilocybin is effective safe and well-tolerated by tracking changes in depressive symptoms suicidality and side effects This study will also see if a second dose of psilocybin has an effect on quality of life functioning cognition thinking reasoning remembering and how long depressive symptoms improve or worsen after psilocybin is administered
Detailed Description:
During the past decade there has been increased interest in the use of psilocybin as a novel treatment for mental health disorders including treatment-resistant depression TRD Recent studies have suggested that psilocybin has the potential to relieve depressive symptoms when combined with psychotherapy ie psilocybin-assisted psychotherapy PAP Each psilocybin dosing session requires the use of extensive resources including two specialized therapists supporting the patient for 6-8 hours per dosing session If two doses of psilocybin prove to be more effective than a single dose of psilocybin in relieving depressive symptoms then two doses should be the standard intervention for future trials and clinical application However if a second dose of psilocybin does not offer increased anti-depressant benefit from the first dose then a second dose of psilocybin would only increase the risk of adverse side effects and cost of treatment Therefore the purpose of this study is to determine whether a second dose of psilocybin provides better efficacy safety and tolerability than a single dose The investigators hypothesize that two doses of psilocybin will be more beneficial compared to a single dose and that there will be no significant difference between the groups one dose versus two doses in safety or tolerability
The primary objective of assessing antidepressant efficacy will be evaluated by the change in the Montgomery-Åsberg Depression Rating Scale MADRS between baseline and Week 8 Safety and tolerability will be assessed using standardized adverse effects monitoring in addition to close participant monitoring during the dosing day eg blood pressure changes dissociative and psychotomimetic effects treatment-emergent manic symptoms and suicidality Secondary objectives include evaluating the effects of one versus two psilocybin doses on suicidality quality of life functioning cognition and duration of clinical benefits during the six month observational follow-up period Exploratory objectives include evaluating predictors of response such as static and dynamic clinical factors and expectancy effects and cost-effectiveness of one versus two psilocybin doses
The primary objective of assessing antidepressant efficacy will be evaluated by the change in the Montgomery-Åsberg Depression Rating Scale MADRS between baseline and Week 8 Safety and tolerability will be assessed using standardized adverse effects monitoring in addition to close participant monitoring during the dosing day eg blood pressure changes dissociative and psychotomimetic effects treatment-emergent manic symptoms and suicidality Secondary objectives include evaluating the effects of one versus two psilocybin doses on suicidality quality of life functioning cognition and duration of clinical benefits during the six month observational follow-up period Exploratory objectives include evaluating predictors of response such as static and dynamic clinical factors and expectancy effects and cost-effectiveness of one versus two psilocybin doses
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?:
False
Is an FDA AA801 Violation?:
None