Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05383313
Status:
RECRUITING
Last Update Posted:
2022-05-20
First Post:
2021-09-07
Brief Title:
Psilocybin Versus Ketamine in Treatment-Resistant Depression
Sponsor:
National Institute of Mental Health Czech Republic
Organization:
National Institute of Mental Health Czech Republic
Study Overview
Official Title:
Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression
Status:
RECRUITING
Status Verified Date:
2021-09
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:
PSIKET_001
Brief Summary:
The main goal is to compare the antidepressant effects of psilocybin and ketamine in patients with TRD versus the antidepressant inactive substance midazolam The primary endpoint will be the antidepressant effect on the Montgomery- Asberg Depression Rating Scale MADRS 24 hours after treatment the key secondary endpoints being the duration of antidepressant effect the number of responses and remissions and the time to standard antidepressant treatment during 3 months of observation The exploratory part of the study aims to monitor changes in the functional brain states using simultaneous EEG fMRI before treatment versus 1 day and 1 week after Based on literature data and recent data from healthy volunteers who participated in a previous study with psilocybin the investigator will correlate antidepressant effects of drugs using psychometric scales and reactions to emotionally salient stimuli eye tracker with entropy and functional connectivity measures Finally the investigator will explore the role of plasmatic neurobiological biomarkers in depression BDNF prolactin ACTH and oxytocin
Detailed Description:
The main aim of the study is to verify the efficacy and safety of a single dose of psilocybin 20 mg in the treatment of TRD in adults in a randomized clinical trial with active comparator ketamine 200 mg rapid onset acting antidepressant and negative control midazolam 5 mg drug with no antidepressant properties Primary objective 1 verification of the rapid antidepressant effect of psilocybin compared to ketamine using the MADRS scale at 24 hours Secondary objectives 1 on days 3 7 and 14 and 3 4 5 6 8 and 12 weeks after application of the substances evaluate compare a the duration of effects of both substances using the MADRS scale b antidepressant effects according to the subjective evaluation of patients - QIDS scale c response rate 50 reduction on the MADRS scale and remission MADRS 10 2 time to return of depressive symptoms defined according to the criteria for the use of antidepressants within 12 weeks 3 safety profile of study medication Exploratory objectives 1 Evaluate the antidepressant effect depending on a the intensity of acute psychological effects assessed using the subjective scale of 5D-ASCs and the objective scale of BPRS b depending on the retrospective assessment of persistent effects using the Persisting effects scale c the degree of eye contact with negative and neutral emotion faces measured by eye-tracking before and after treatment on days 1 and 7 2 To evaluate the neurobiology of the antidepressant effect in relation to a plasma levels of the major metabolite of psilocin markers of neuroplasticity antidepressant effect and stress BDNF prolactin oxytocin ACTH at 90 min 3 and 6 h after administration of study medication compared to pre-administration levels b changes in resting-state brain activity connectivity entropy measured by simultaneous EEG fMRI functional imaging methods before and after 1 and 7 days after treatment
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