Project Details page

Exclusion Criteria

Psychiatric Exclusion Criteria:
1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia,
schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance
induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2).
2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement.
3. Borderline personality disorder as demonstrated by medical history or the Mini International
Neuropsychiatric Interview Plus (MINI plus) – borderline personality disorder module.
4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa, as assessed by medical history and a structured clinical interview (MINI 7.0.2).
5. Psychiatric inpatient within the past six months prior to Screening.
6. Use of all invasive somatic treatment including electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, and/or ablative neurosurgery during the current depressive episode. NOTE: currently having an implanted device also excludes the participant.
7. Use of all non-invasive somatic treatments including transcranial magnetic stimulation within the past six months prior to Screening.
8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of Part A of the study (nine weeks after initial COMP360 administration). Psychological therapies cannot have been initiated within 30 days prior to Screening.
9. Alcohol or substance use disorder within the 12 months prior to Screening, as determined by DSM-5 assessed via the MINI 7.0.2.
10. Exhibiting significant suicide risk, as defined by:
a. suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline;
b. demonstrating suicidal behaviours or non-suicidal self-injury within the past six months, or;
c. clinical assessment of significant suicidal risk or risk of self-injury during participant
interview.
11. Depression secondary to a medical or drug-related cause in the opinion of the Investigator.
12. Other personal circumstances or behaviour judged by the Investigator to be incompatible with establishment of rapport or the safe exposure to COMP360.
13. Participant report of first-degree family history of schizophrenia or bipolar I disorder.
14. Exposure to psilocybin, or any other classic psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine
(5-MeO-DMT), or peyote during the past year or current depressive episode. NOTE: up to 15% of
the participant population will be accepted with prior use of classic psychedelics, provided they did not use them within the 12 months prior to Screening or during their current depressive episode, including microdosing. Additionally, the participant must agree not to use psychedelics for the duration of the study follow-up so as not to confound results.
15. Exposure to COMP360 psilocybin therapy prior to Screening.
General Medical Exclusion Criteria:
1. Participants who are pregnant, nursing, or planning a pregnancy.
2. Participants who engage in sexual intercourse which could result in pregnancy, and who do not agree to use a highly effective contraceptive method (see Section 8.1.1) throughout their
participation in the study and for at least three months after their last COMP360 administration.
3. Participants of childbearing potential who do not have a negative serum pregnancy test at Screening, and negative urine pregnancy test at Baseline and on the day of first COMP360 administration (pre-administration on Day 1).
4. Participants who plan to donate sperm within three months following their last COMP360
administration.
5. Cardiovascular conditions: lifetime history of stroke, lifetime myocardial infarction, uncontrolled hypertension (resting blood pressure >140/90 mmHg), tachycardia (resting heart rate >100 beats per minute), elongated QT interval corrected by Fridericia’s formula (interval >450 msec for men and >470 msec for women), or clinically significant arrhythmia (<1 year prior to signing the ICF).
6. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined by haemoglobin A1c >8% at Screening) or a history of diabetic ketoacidosis, hyperglycaemic coma, or severe
hypoglycaemia with loss of consciousness (<3 months prior to signing of ICF).
7. Unstable existing thyroid disease/disorder as indicated by unstable thyroid hormone dosage
<3 months prior to Screening; or out-of-range thyroxine levels with an out-of-range
thyroid-stimulating hormone value irrespective of thyroid history.
8. Seizure disorder.
9. Positive urine drug screens for illicit drugs or drugs of abuse at Screening will be reviewed with participants to determine the pattern of use and eligibility will be determined at the Investigator’s discretion in conjunction with the Medical Monitor.
10. Clinically significant results on vital signs, ECG, or physical examination at Screening or Baseline, or laboratory tests at Screening.
11. Any other clinically significant major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.
12. Current enrolment in an interventional study or participation in such within six months of Screening.
13. Hypersensitivity to the IP or any of the excipients.