Comparing Risperidone with Psilocybin for treatment resistant depression

Exclusion

• −Any disability that may prevent the participant from completing study requirements (e.g., non-correctable clinically significant sensory impairment such as not hearing well enough to communicate with study personnel during scans, or physical disability that does not allow them to lie still on the scanner bed for 1-2 hours);
• −Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.
• −History of allergy or contraindication to risperidone
• −Treatment with another investigational drug or other intervention within 30 days of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (V1);
• −Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
• −Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;
• −Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;
• −Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical history form and discussions with the participant;
• −Presence of baselineBaselineYour starting measurements, taken before treatment begins.Read more → prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;
• −Current or past traumatic brain injury or other neurological/neurodegenerative disorder
• −Unable or unwilling to undergo PET or MRI scanning (e.g. claustrophobia, pacemaker);
• −Blood disorders, disorders of coagulation, or ongoing use of anticoagulant medication
• −Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.
• −Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;
• −Participant exceeds the annual or lifetime amount of radiation
• −Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;