Depression Mental and Behavioural Disorders
Conditions
Interventions
The study will run through stages progressively, with one stage running until finished and then moving to the next stage
Phase 1
Stage 1
Overview
The main purpose of this stage is to assess the d
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 - 65 years 2. Provide a personally signed and dated informed consent document indicating that the participant has been informed of and agrees to comply with all aspects of the study 3. Be willing and able to comply with scheduled visits, dosing plan, laboratory trials and any other necessary procedures 4. Have previous experience with psychedelics or other ‘mind-altering’ substance (e.g. ketamine)
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Any current active mental health diagnosis. For participants with a past mental health diagnosis, current absence of an active mental health diagnosis will be determined by a clinician. 3. History of bipolar disorder, personality disorder or psychotic disorder, as assessed by a combination of prior records and by the clinician at the time of screening. 4. Physical health problems incompatible with receiving psilocybin 5. Historic significant suicidal thoughts/behaviour (Colombia-Suicide Severity Rating Scale (C-SSRS > 3)) 6. Any current suicidal ideation (C-SSRS > 0) 7. Clinically significant biochemical or ECG abnormalities at screening 8. Currently using regular psychotropic medication 9. Use of psychedelic drugs in the last month 10. Current enrolment in a drug study 11. Excessive use of caffeine or nicotine as determined by clinical assessment 12. Alcohol dependence as determined by clinical assessment 13. A positive DoA or breathalyser test at admission on the dosing day Exclusion criteria (sleep stages (2 and 4)) 1. Clinically significant abnormalities with sleep as assessed by PSQI and clinical judgement
Countries
England, United Kingdom
Contacts
Public ContactRaphael Rifkin-Zybutz
Outcome results
None listed