Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI

This trial (n=20) investigates the effects of psilocybin (18.2mg/70kg) on several brain measures and sleep quality. Healthy volunteers aged between 28 and 65 years with no psychiatric history or family history of psychotic disorders will participate.

Psilocybin, administered orally via capsules, will be compared to a placebo to analyze its effects on brain connectivity using functional magnetic resonance imaging (fMRI) and quantitative electroencephalography (qEEG). The study will also assess psychopathological changes associated with psilocybin administration. Secondary objectives include comparing the validity of findings in the human model with an analogous animal model and findings in patients suffering from schizophrenia, with a focus on understanding the role of the serotonergic system in the etiology of schizophrenia.

Status Completed
Results Published Yes
Start date 18 June 2014
End date 18 June 2016
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 20
Sex All
Age 28- 65
Therapy No

Trial Details



Trial Number 2012-004579-37

Sponsors & Collaborators

National Institute of Mental Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Papers

Cross-Species Evidence for Psilocin-Induced Visual Distortions: Apparent Motion Is Perceived by Both Humans and Rats
This cross-species experimental study (n=21 humans; n=10 rats) finds that psilocin (18.2mg/70kg for humans; 0.3mg/kg for rats) impairs the ability to distinguish between static and moving images in both humans and rats. In humans, the impairment aligns with psilocin plasma levels and self-reported hallucination intensity. In rats, the effect is specific to motion perception, providing the first evidence of psilocin-induced visual distortions across species.

The phenomenology of psilocybin's experience mediates subsequent persistent psychological effects independently of sex, previous experience, or setting
This double-blind, placebo-controlled, cross-over study (n=40) found that two doses of psilocybin (18.2mg/70kg) administered at least 56 days apart (avg. 15 months) produced positive lasting effects in healthy individuals regardless of previous psychedelic experience, sex, or setting, with challenging experiences in controlled environments not causing adverse outcomes, supporting psilocybin's psychological safety for repeated use.

The Effects of Daytime Psilocybin Administration on Sleep: Implications for Antidepressant Action
This randomized, double-blind, placebo-controlled, within-subjects study (n=17) investigated the effects of psilocybin (18.2mg/70kg) on brain rhythms during sleep and found that it increased the transition period from wakefulness to REM sleep and reduced the duration of the REM period. These results are in line with the effects of other antidepressants and diametrically opposed to biomarkers of depression that include shortened wakefulness to REM transitions and increased REM duration and density.

Psilocybin disrupts sensory and higher order cognitive processing but not pre-attentive cognitive processing—study on P300 and mismatch negativity in healthy volunteers
This double-blind placebo-controlled cross-over study (n=20) found that psilocybin (18.2mg/70kg) disrupted certain auditory-related brain signals (P300, not MMN) which decreased in amplitude in correlation with higher psilocin serum levels (and more intense psychedelic experiences).

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.