Disorders of consciousness as unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) after a coma due to acquired brain injury.
Conditions
Interventions
Product Name: PEX010 (Psilocybin Capsules 25mg)
Product Code: PEX010
Pharmaceutical Form: Capsule
INN or Proposed INN: Dry extract from Psilocybe cubensis (15-25:1), Extraction solvent: methanol
Other
Sponsors
University of Liege
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy participants - 18-55 years old - No history of psychiatric, psychotic or neurologic disorders - No history of psychiatric disorders in first-degree relatives Inclusion criteria for DoC patients - 18-55 years old - No history of psychiatric or psychotic in first-degree relatives - Clinically stable, not dependent on medical ventilators for respiration - Diagnosed as in an UWS or MCS according to the international criteria and based on at least 2 consecutive SECONDs/CRS-R - More than 28 days post-insult 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy participants: - Excessive use of alcohol (>30 units per week) - Renal failure - Coronary insufficiency - Pregnancy - Use of medication within the week before the experiment unless prescribed by general practitioner and with no interaction with the nervous system - History of stroke - Current angina - Uncontrolled hypertension - Abnormal electrical activity of the heart (ECG) (e.g. atrial fibrillation) - Artificial heart valve - Transient ischemic attack within the last year - Current epilepsy Exclusion criteria: - History of previous neurological impairment other than related to their acquired brain injury - History of psychiatric or psychotic disorders - Renal failure - Coronary insufficiency - Contraindication to MRI, EEG, or PET (e.g., electronic implanted devices, external ventricular drain) - Use of serotoninergic agonists or antagonists (e.g., selective serotonin reuptake inhibitors, serotonin–norepinephrine reuptake inhibitors) - Ritonavir (Norvir), an anti-retroviral medication used to treat HIV - Tricyclic antidepressants, such as amitriptyline and nortriptyline (Pamelor) - Monoamine oxidase inhibitors (MAOIs), antidepressants such as isocarboxazid (Marplan) and phenelzine (Nardil) - Current angina - Uncontrolled hypertension - Artificial heart valve - Transient ischemic attack within the last year - Pregnancy - Current epilepsy - Diabetes or obesity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This clinical trial aims to evaluate the efficacy of oral psilocybin for the treatment of patients with disorders of consciousness (DoC) after a coma and assess the prevalence of responders. ;Secondary Objective: This study aims to also better characterize the phenotype of potential good candidates to psilocybin treatment and identify a set of biomarkers that correlate with responsiveness (or non-responsiveness) to the therapy, as well to help underpinning the neural networks underlying the modulating action of psilocybin on consciousness and brain complexity. ;Primary end point(s): New signs of consciousness assessed via the Simplified Evaluation of CONsciousness Disorders (SECONDs);Timepoint(s) of evaluation of this end point: Two sessions separated by 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Change of complexity measured with the Lempel-Ziv Complexity 2-Changes in EEG spectral power within fixed bands or dynamic connectivity using median spectral connectivity and graph-theoretic topology metrics 3-Changes in the probability of consciousness using a multivariate EEG a classifier based on a machine-learning approach using 120 EEG markers 4-Difference of PET, MRI, or EEG in the baseline assessment between responders and not-responders;Timepoint(s) of evaluation of this end point: Recording with EEG done from 20 minutes before giving psilocybin to a maximum of 150 minutes drug intake | — |
Countries
Belgium
Contacts
Public ContactComa Science Group
University of Liege
Outcome results
None listed