Inclusion criteria: a) Men and women at age between 28 and 65 years b) healthy volunteers with negative psychiatric history (severe mental illnesses that meet the criteria of ICD 10 F0.X - F99.X) c) negative family psychiatric history in terms of psychoses up to 2nd generation of relatives
Conditions
Interventions
Product Name: Psilocybin
Product Code: THC-1143G
Pharmaceutical Form: Capsule
INN or Proposed INN: PSILOCYBINE
CAS Number: 520-52-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
National Institute of Mental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women at the age between 18 to 65 years 2. Healthy volunteers with negative psychiatric anamnesis, including harmful use, abuse and addiction on addictive substances 3. Negative family psychiatric anamnesis without psychotic disorders to II. generation of relatives Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) pregnant women b) A volunteer with intracranial hypertension, severe arterial hypertension or pulmonary hypertension c) A volunteer after stroke d) A volunteer with congestive heart failure e) Volunteer with pacemaker f) A volunteer with a metal clamp in the head and face g) A volunteer with celiac disease h) A left-handed volunteer i) any use of regular hormonal contraception except mediakce j) Persons in a dependent position - undergraduate students of medical faculties k) Persons in a dependent position - students of other faculties aged less than 28 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the project is the study of functional brain connectivity in pharmacological model of psychosis induced by acute administration of psilocybin. Brain connectivity under resting condition and during activation tasks will be studied using functional magnetic resonance imaging (fMRI) and quantitative electroencephalography (qEEG) and correlated with psychopathological changes.;Secondary Objective: The secondary objective is to compare the validity of findings in human model with analogous animal model and with findings in patients suffering from schizophrenia. The focus is to understand the role of serotonergic system in the etiology of schizophrenia and to bring implications for treatment.;Primary end point(s): 1) During resting fMRI recording application of psilocybin will lead to analogous changes of regional activity and brain (fMRI) as in non-medicated schizophrenic patients (increase in frontal and temporal areas). 2) Submission of psilocybin, compared with placebo, will be associated with lower cognitive activation of the left DLPFC, rostral/dorsal part of ACC and left thalamus. 3) Psilocybin will induce changes in EEG spectra and in current density in 3D space of brain (LORETA) that will be comparable with human data in schizophrenic patients. 4) Application of psilocybin will lead to a reduction in EEG coherence and to increase of the phase shift between the frontal and temporal brain regions. 5) evaluation of the effects of psilocybin using a battery of neuropsychiatric tests (BPRS, ASCS and Hallucinogen Rating Scale (HRS)) 6) the correlation of the results described above from MRI and EEG with effects of psilocybin described using neuropsychiatric tests (BPRS, ASCS and Hallucinogen Rating Scale (HRS));Timepoint(s) of evaluation of this end point: The timepoint of primary end points will be at the end of the whole study, we assumed December 2016. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): g) comparison of changes in functional connectivity after administration of psilocybin with published findings in non-medicated schizophrenic patients h) the implications of the findings in the context of the neurobiology of schizophrenia and the use of serotonergic-acting antipsychotics;Timepoint(s) of evaluation of this end point: The timepoint of secondary end points will be at the end of the whole study, we assumed December 2015. | — |
Countries
Czech Republic
Contacts
Public ContactApplied brain electrophysiology
National Institute of Mental Health
Outcome results
None listed