Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624137
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Computer Game Qualitative and MEGEEG Assessment of Serotonergic Psychedelics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Computationally Electrophysiologically and Qualitatively Characterizing Serotonergic Psychedelics Transdiagnostic Therapeutic and Pro-Psychotic Effects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn how the brains information processing changes during and following administration of serotonergic psychedelics psilocybin NN-DimethyltryptamineDMT Lystergic Acid DiethylamideLSD etc for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University The main questions it aims to answer are
1 Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence What about 1 day 5-14 days and 4-6 weeks after use
2 Do serotonergic psychedelics cause long-lasting side-effects in how people perceive see hear feel etc the world and how easily people change their beliefs
3 How does the brains electrical activity change after using serotonergic psychedelics How does the balance between excitation and inhibition change while under their effect
4 Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics
Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics
Participants will have the opportunity to do some combination of the following
1 Online computer assessments consisting of games and questionnaires that probe how participants think
2 Magnetoencephalography MEG or electroencephalography EEG with eyes closed and with repeated clicks images or sensations delivered
3 A magnetic resonance imaging MRI scan
4 Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom
1 Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence What about 1 day 5-14 days and 4-6 weeks after use
2 Do serotonergic psychedelics cause long-lasting side-effects in how people perceive see hear feel etc the world and how easily people change their beliefs
3 How does the brains electrical activity change after using serotonergic psychedelics How does the balance between excitation and inhibition change while under their effect
4 Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics
Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics
Participants will have the opportunity to do some combination of the following
1 Online computer assessments consisting of games and questionnaires that probe how participants think
2 Magnetoencephalography MEG or electroencephalography EEG with eyes closed and with repeated clicks images or sensations delivered
3 A magnetic resonance imaging MRI scan
4 Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom
Detailed Description:
Mounting evidence suggests that serotonergic psychedelics SPs eg psilocybin LSD reduce symptoms across many mental illnesses with rapid sustained effects from single interventions They also cause persisting positive effects in the general population and those without mental illness This improved wellness comes at the cost of acute psychosis-like effects that sometimes persist in weakened forms or rarely as prolonged episodes of psychosis Understanding the mechanism underlying these dual effects may help maximize therapeutic effect and minimize unwanted outcomes
The reason SPs cause therapeutic change and also cause psychotic-like effects regardless of whether one has a mental illness may be because they alter the basic machinery that the brain uses to process all information SPs seem to shift processing-in both how we perceive seeing hearing etc and learn-to rely more on new incoming information over previously learned information Essentially SPs shift the brain into an extreme learning mode that allows it to modify harmful thought patterns associated with many mental illnesses but that may also be similar to the brain states of early psychosis
Participants in this study will opt-in to complete various measures to be completed before during and after being administered a serotonergic psychedelic through a clinical trial at Yale University
How participants brains process information will be assessed by
1 Playing 3-4 computer games that measure how people see hear and learn These will be completed 1-30 days before receiving the serotonergic psychedelic the day they receive the serotonergic psychedelic once psychologically acceptable and permitted by relevant trial researchers the day after 5-14 days after and 4-6 weeks after
2 MEG or EEG to measure the brain activity responsible for representing new vs old information-and structural MRI to determine where the activity is coming from The MEGEEG will be done the day before day of and day after administration of the serotonergic psychedelic The MRI can be done before after or during the trial
They behaviors that accompany these changes will be assessed by
1 Validated online questionnaires at the same time points as the computer games
2 Semi-structured interviews about what participants day-to-day experiences are like and how they have changed after taking a serotonergic psychedelic These may be done 2-5 days after using a psychedelic or at the same time that clinical trial staff do their interviews
Participants participating in a trial with single-arm placebo-controlled study design that includes a placebo arm may only complete these measures around a placebo administration Those in a trial with a crossover design may complete these measures twice except for day 1-30 and 4-6 week time points Those opting to complete open-label administrations after study completion may complete relevant time points
The primary objectives are to
1 Investigate how serotonergic psychedelics change brain reliance on new vs old information in perception and belief-updating while under the influence
2 Investigate how serotonergic psychedelic change brain reliance on new vs old information in perception and belief updating at short and long-term follow-up
3 Investigate whether serotonergic psychedelics cause side effects in peoples perception attention and belief updating that are both healthy and psychosis-like
4 Investigate how serotonergic psychedelics acutely alter excitationinhibition EI balance in the brain
5 Investigate whether there are any persisting changes in resting state EEG power or EI balance
The secondary objectives are to
1 Investigate whether changes in brain information processing can explain therapeutic effects of serotonergic psychedelics
2 Investigate whether changes in brain information processing can predict who will respond positively to serotonergic psychedelics
3 Investigate whether changes in brain information processing can explain psychotic-like side effects of serotonergic psychedelics
4 Investigate whether changes in brain information processing can predict who will have stronger psychotic-like side effects from serotonergic psychedelics
5 Investigate whether acute or persisting changes in EI balance predict therapeutic or psychotic effects of serotonergic psychedelics
The reason SPs cause therapeutic change and also cause psychotic-like effects regardless of whether one has a mental illness may be because they alter the basic machinery that the brain uses to process all information SPs seem to shift processing-in both how we perceive seeing hearing etc and learn-to rely more on new incoming information over previously learned information Essentially SPs shift the brain into an extreme learning mode that allows it to modify harmful thought patterns associated with many mental illnesses but that may also be similar to the brain states of early psychosis
Participants in this study will opt-in to complete various measures to be completed before during and after being administered a serotonergic psychedelic through a clinical trial at Yale University
How participants brains process information will be assessed by
1 Playing 3-4 computer games that measure how people see hear and learn These will be completed 1-30 days before receiving the serotonergic psychedelic the day they receive the serotonergic psychedelic once psychologically acceptable and permitted by relevant trial researchers the day after 5-14 days after and 4-6 weeks after
2 MEG or EEG to measure the brain activity responsible for representing new vs old information-and structural MRI to determine where the activity is coming from The MEGEEG will be done the day before day of and day after administration of the serotonergic psychedelic The MRI can be done before after or during the trial
They behaviors that accompany these changes will be assessed by
1 Validated online questionnaires at the same time points as the computer games
2 Semi-structured interviews about what participants day-to-day experiences are like and how they have changed after taking a serotonergic psychedelic These may be done 2-5 days after using a psychedelic or at the same time that clinical trial staff do their interviews
Participants participating in a trial with single-arm placebo-controlled study design that includes a placebo arm may only complete these measures around a placebo administration Those in a trial with a crossover design may complete these measures twice except for day 1-30 and 4-6 week time points Those opting to complete open-label administrations after study completion may complete relevant time points
The primary objectives are to
1 Investigate how serotonergic psychedelics change brain reliance on new vs old information in perception and belief-updating while under the influence
2 Investigate how serotonergic psychedelic change brain reliance on new vs old information in perception and belief updating at short and long-term follow-up
3 Investigate whether serotonergic psychedelics cause side effects in peoples perception attention and belief updating that are both healthy and psychosis-like
4 Investigate how serotonergic psychedelics acutely alter excitationinhibition EI balance in the brain
5 Investigate whether there are any persisting changes in resting state EEG power or EI balance
The secondary objectives are to
1 Investigate whether changes in brain information processing can explain therapeutic effects of serotonergic psychedelics
2 Investigate whether changes in brain information processing can predict who will respond positively to serotonergic psychedelics
3 Investigate whether changes in brain information processing can explain psychotic-like side effects of serotonergic psychedelics
4 Investigate whether changes in brain information processing can predict who will have stronger psychotic-like side effects from serotonergic psychedelics
5 Investigate whether acute or persisting changes in EI balance predict therapeutic or psychotic effects of serotonergic psychedelics
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