Treatment-resistant depression Mental and Behavioural Disorders
Conditions
Interventions
Volunteers will receive both of the following treatments, one at each of the study visits in a random order (either test then reference or reference then test): 25 mg COMP360 given as 1 x 25 mg capsul
Sponsors
COMPASS Pathfinder Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed ICF 2. Male or female aged between 18 and 55 years old at screening 3. Body mass index between 18.5 and 30.0 at screening 4. Weight =50 kg at screening 5. Non-smoker (including e-cigarettes) for at least 12 months prior to screening 6. Willing to comply with fasting and food intake requirements 7. Able to complete all protocol required assessments and agree to comply with all study visits
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/08/2022: 1. Current or clinically relevant history of any psychotic disorder, bipolar disorder, borderline personality disorder, major depression, panic disorder, post-traumatic stress disorder, generalised anxiety disorder, obsessive-compulsive disorder, or eating disorder, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview, Version 7.0.2 [MINI Version 7.0.2] and Mini International Neuropsychiatric Interview, Version 7.0.2 – Plus borderline personality module [MINI-Plus]) 2. A history of suicide attempts, suicidal ideation or suicidal behaviour as determined by the C-SSRS at Screening or at Day 1; or clinical assessment of significant suicidal risk or risk of self-injury identified during participant interview 3. Satisfying diagnostic criteria for alcohol or substance use disorder, as determined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (MINI 7.0.2) within 12 months prior to Screening 4. Use of pharmacological compounds for psychiatric or neurological conditions acting on the central nervous system within 30 days (or five half-lives, whichever is longer) prior to Screening 5. In first-degree relatives, a history of psychotic disorders or mood disorders, including bipolar disorders and depressive disorders 6. Other personal circumstances or behaviour judged by the investigator to be incompatible with the establishment of rapport or the safe exposure to COMP360 7. Exposure to psilocybin or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within 12 months prior to Screening. Additionally, participants must agree not to use psychedelics other than COMP360 for the duration of the study. 8. Pregnancy, lactating or planning a pregnancy 9. Engagement in sexual intercourse which could result in pregnancy, must agree to use a highly effective contraceptive method throughout their participation in the study and for 3 months after their final COMP360 administration. Participants of childbearing potential must have a negative serum pregnancy test at Screening, and a negative urine pregnancy test the day prior to COMP360 administration (Day -1 of each treatment period). 10. Participants should be informed not to donate eggs for the duration of the study period and for 30 days after their final COMP360 administration, or to donate sperm for the duration of the study period, and for at least three months after their final COMP360 administration 11. Cardiovascular conditions: 11.1. Lifetime history of stroke 11.2. Lifetime myocardial infarction 11.3. Clinically significant arrhythmia (140/90 mmHg at screening or prior to COMP360 administration on Day 1, following triplicate readings 11.5. Elongated QT interval corrected by Fridericia (QTcF; interval >450 msec for men and >470 msec for women) at screening or prior to COMP360 administration on Day 1, following triplicate readings. 12. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined by haemoglobin A1c [HbA1c] >8% at Screening) or a history of diab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma PK parameters for psilocin, measured by analysing blood samples taken on the day of dosing for a 24-hour period, in both treatment periods, as per the clinical protocol: 1.1. Peak exposure of psilocin (Cmax) 1.2. Area under the concentration-time curve from zero to 24 hours (AUC0-24h) of psilocin 1.3. Area under the concentration-time curve from zero to infinity (AUC0-inf) of psilocin | — |
Secondary
| Measure | Time frame |
|---|---|
| The endpoints will be measured by analysing blood samples taken on the day of dosing for a 24-hour period, in both treatment periods, as per the clinical protocol 1. Plasma PK parameters for psilocin, psilocybin, 4-hydroxyindoleacetic acid (4-HIAA) and psilocin-O-glucuronide including: 1.1. Area under the concentration-time curve from zero to 24 hours (AUC0-24h) 1.2. Area under the concentration-time curve from zero to infinity (AUC0-inf) 1.3. Peak exposure (Cmax) 1.4. Time to reach peak exposure (tmax) 1.5. Time to the first measurable timepoint (tlag) 1.6. Elimination half-life (t1/2) 1.7. Last measurable concentration (Clast) 1.8. Apparent total clearance of the drug from plasma after oral administration (CL/F) (psilocybin only) 1.9. Apparent volume of distribution at terminal phase (Vd/F) (psilocybin only) 2. Safety endpoints measured via physical examinations and through psychiatric assessment questionnaires throughout the study, from screening (Day -28) until the follow-up phone call (up to 6 days post-dosing in period 2): 2.1. Adverse events (AEs) 2.2. Electrocardiogram (ECG) 2.3. Vital signs 2.4. Clinical laboratory tests 2.5. Suicidality assessed via the Columbia-Suicide Severity Rating Scale (C-SSRS) 2.6. Brief Psychiatric Rating Scale – positive symptoms subscale (BPRS+) | — |
Countries
England, United Kingdom
Contacts
Public ContactZainib Shabir
Outcome results
None listed