Psychedelic Therapy Inclusion and Exclusion Criteria

Certain types of patient are more at risk of adverse side effects to psychedelic medicine. Therefore, a judgement needs to be made pre-administration to recommend to the patient where it is safe to take the medicine or not. Below is a list of inclusion criteria and exclusion criteria extracted from clinical data up to July 2023.

Inclusion Criteria

Participants meeting all the following inclusion criteria at Screening were considered for admission into the study.

1.     Signed Informed Consent Form (ICF).

2.     18 years of age or older at Screening.

3.     At least moderate major depressive disorder (MDD) (single or recurrent episode as informed by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); if single episode duration of ≥3 months and ≤2 years) based on medical records, clinical assessment, and documented completion of the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.

4.     17 item, Hamilton Depression Rating Scale total score ≥18 at Screening and Baseline.

5.     Failure to respond to an adequate dose and duration of two, three, or four pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ. Augmentation with an add on treatment counted as a second treatment, provided it was approved for the adjunctive treatment of MDD in that country.

6.     McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) <7 at Screening.

7.     Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

Exclusion Criteria

Participants meeting any of the following exclusion criteria at Screening were not enrolled into the study.

Psychiatric Exclusion Criteria:

1.     Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, MSI-BPD and a structured clinical interview (MINI version 7.0.2).

2.     Prior electroconvulsive therapy and/or ketamine for current episode.

3.     Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI at Screening and Baseline with the exception of those taking MAOI containing psychedelics including but not exclusively ayahuasca.

4.     Current psychological therapies that would not remain stable within 21 days the psychedelic administration session. Psychological therapies cannot be initiated within 21 days of Baseline.

5.     Current (within the last year) alcohol or substance use disorder as informed by DSM-5 (diagnosed by MINI version 7.0.2) at Screening.

6.     Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year, at Screening or at Baseline, or; (2) suicidal behaviours within the past year, or; (3) clinical assessment of significant suicidal risk during participant interview.

7.     Depression secondary to other severe medical conditions according to clinicians’ judgement.

8.     Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current depressive episode.

General Medical Exclusion Criteria

1.     Females who are pregnant, nursing, or planning a pregnancy. Male and female participants who engaged in sexual intercourse which could result in pregnancy, had to agree to use a highly effective contraceptive method throughout their participation in the study. Females of childbearing potential must have had a negative urine pregnancy test at Screening and Baseline.

2.     Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), hypertension (blood pressure >140/90 mmHg), or clinically significant arrhythmia within 1 year of signing the ICF.

3.     Uncontrolled or insulin-dependent diabetes.

4.     Seizure disorder.

5.     Positive urine drug screen for illicit drugs or drugs of abuse at Screening and Baseline. Any positive urine drug test was 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.

6.     Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening.

7.     Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening.

8.     Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram (ECG), or laboratory tests at Screening.

9.     Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may have interfered with the interpretation of the study results or constitute a health risk for the participant if he/she took part in the study.

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