Testing Psilocybin for treatment-resistant depression

Exclusion

• −Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history (within preceding six months) , uncontrolled hypertension (consistent blood pressure readings above 160/100 mmHg: measured twice with one hour between measurements), low blood pressure (blood pressure reading lower than 90/60mmHg), labile blood pressure (defined as episodes of both high and low blood pressure within a 24-hour period), recent myocardial infarction (within preceding six months), all types of cardiac arrhythmia, severe coronary artery disease (symptomatic with chest pain, angina heart palpitations or shortness of breath), or moderate to severe renal impairment (eGFR of below 40 mL/min ) or hepatic impairment (as a Child-Pugh score of B or C, determined through liver function tests);
• −An individual who meets any of the following criteria will be excluded from participation in this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →:
• −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);
• −Brain stimulation treatment within 6 months of Screening (V1);
• −Use of psychedelics within 6 months of Screening (V1);
• −Have initiated psychotherapy in the preceding 4 weeks prior to Screening (V1);
• −Have active suicidal ideation with intent and plan, certified by the Mental Health Act (MHA), determined by a study physician;
• −Any DSM-5 lifetime diagnosis of mania or hypomania, 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 MINI diagnostic interview;
• −Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition), 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 (defined as greater than 450 milliseconds (ms) in men and greater than 460 ms in women) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors ;
• −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) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding;
• −Have a DSM-5 diagnosis of moderate to severe substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;