DEUPSILOCIN BESILATE for Major depressive disorder

Inclusion criteria

• {"criterion_text":"-Participant has successfully completed either the APPROACH or EMBRACE trial and received BOTH dose administrations of trial medication."}
• {"criterion_text":"-Participant has continued the same antidepressant medication at the stable dose/day throughout the 12-week APPROACH or EMBRACE trial."}
• {"criterion_text":"-If the participant was engaged in a psychotherapeutic relationship in the APPROACH or EMBRACE trial, they agree to remain in stable and consistent therapy for the remainder of the trial with no changes in the frequency or the setting throughout the trial."}
• {"criterion_text":"-Participants can refrain from nicotine use during the dosing session (up to 8 hours)."}
• {"criterion_text":"-Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant’s final dose of IP."}
• {"criterion_text":"-Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP."}
• {"criterion_text":"-Female participants must have a negative pregnancy test at Baseline (the end of trial [EOT] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day."}
• {"criterion_text":"-Postmenopausal status will not be confirmed with follicle-stimulating hormone (FSH) levels. Therefore, participants who may have become post menopausal in the preceding trial but the status was unable to be confirmed, must be willing to continue with the contraception requirements"}
• {"criterion_text":"-Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)."}

Exclusion criteria

• {"criterion_text":"-Any concern by the Principal Investigator that a participant may have undiagnosed or newly developed symptoms of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, attention deficit hyperactivity disorder, bipolar disorder, or borderline personality disorder that manifested in the APPROACH or EMBRACE trial."}
• {"criterion_text":"-QT interval corrected for heart rate using Fridericia’s formula >450 msec for males and >470 msec for females following triplicate ECG readings at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial)."}
• {"criterion_text":"-Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial) as defined by Investigator judgment"}
• {"criterion_text":"-Clinical evidence of any new disease and/or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the IP."}
• {"criterion_text":"-Participant has experienced any new onset organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor) or other medical condition associated with seizure or convulsion risk since Screening in the APPROACH or EMBRACE trial."}
• {"criterion_text":"-Safety laboratory values at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial) for aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT) or total bilirubin (TBil) levels ≥1.5 × the upper limit of normal (ULN). These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included only if the Investigator considers that the previous finding will not introduce additional risk factors and will not interfere with interpretation of safety data"}
• {"criterion_text":"-Participants that do not agree to abstain from drugs of abuse for the entire trial and/or do not agree to refrain from alcohol use from 48 hours before each scheduled visit until discharge from the trial site"}
• {"criterion_text":"-Sensitivity or suspected sensitivity to IP noted in the APPROACH or EMBRACE trial"}
• {"criterion_text":"-Participants that are unable to abstain from strenuous exercise within 48 hours before each clinic visit. Other eligibility considerations (e.g., participant personal circumstances, behavior, and/or any current problem or future plans that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator"}
• {"criterion_text":"-Participants capable of producing sperm that are unable to abstain from sperm donation until 12 weeks after final dosing."}
• {"criterion_text":"-Participants of childbearing potential who have a positive urine test and, subsequently, confirmatory serum pregnancy test at the Baseline (the EOT Visit in the APPROACH or EMBRACE trial), OR any time in the trial, OR planning to conceive, OR unwilling to abstain from egg (ova) donation until 12 weeks after final dosing"}
• {"criterion_text":"-New awareness of a participant’s family member being diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives) since Screening in the APPROACH or EMBRACE trial."}
• {"criterion_text":"-Any concern that participants may be at risk of developing serotonin syndrome with dosing of IP in the EXTEND trial"}
• {"criterion_text":"-Participant is unwilling to consent to audio and video recording of psychological support and dosing sessions"}
• {"criterion_text":"-Investigator’s decision that, for any reason, a participant may be unsuitable for enrollment."}
• {"criterion_text":"-Significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C SSRS) at the Baseline of EXTEND (the EOT Visit in the APPROACH or EMBRACE trial), (b) participants have experienced an adverse event of suicidal ideation/attempt or self-harm in the APPROACH or EMBRACE trial, (c) have had a >1 point change in item 1 or 2 of the C SSRS performed at the EOT Visit in the APPROACH or EMBRACE trial, compared to their score on these items from the Screening Visit of the APPROACH or EMBRACE trial"}
• {"criterion_text":"-Use of a prescription medicine other than a stable chronic dose of antidepressant medication, except those permitted during the APPROACH or EMBRACE trial or approved by a Medical Monitor"}
• {"criterion_text":"-Development of clinically relevant abnormal physical health condition or need of treatment for a condition that could interfere with the trial or pose an unacceptable risk to the participant in this trial as judged by the Investigator (including but not limited to neurological, cardiovascular, respiratory, gastrointestinal [including dyspepsia or gastroesophageal reflux disease], hepatic or renal disorder)."}
• {"criterion_text":"-Participants with renal insufficiency (eGFR ≤59 mL/min/1.73 m2)."}
• {"criterion_text":"-Participants with stable hypothyroidism or hyperthyroidism, at Screening in the APPROACH or EMBRACE trial that are unable to continue appropriate medication until the final visit in the EXTEND trial."}
• {"criterion_text":"-Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial."}
• {"criterion_text":"-Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically abnormal results for heart rate (resting supine heart rate >100 beats per minute) or blood pressure (BP) (resting supine systolic BP >139 mmHg or resting supine diastolic BP >89 mmHg) at Baseline (EOT of APPROACH/EMBRACE). Participants with well controlled hypertension and who have been on stable dose/doses of either 1 or 2 allowable antihypertensive medications for ≥4 weeks prior to Baseline are permitted."}

Primary endpoints

• {"endpoint_text":"-Time to first relapse from Baseline of EXTEND trial in participants who have had a stable response in either the APPROACH or EMBRACE trial","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 2 additional doses of IP in EXTEND.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Percentage of participants who are either responders or non-responders in APPROACH or EMBRACE and require 3 additional doses of IP in EXTEND.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Percentage of participants with sustained response defined as absence of a relapse after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score above 50% decrease in MADRS total score permitted.","definition_or_measurement_approach":"Sustained response defined in-text: absence of a relapse after administration of 2 doses of IP with allowance of 1 increase in MADRS total score above a 50% decrease in MADRS total score."}
• {"endpoint_text":"-Percentage of participants with sustained remission defined as MADRS total score ≤10 after administration of 2 doses of IP in APPROACH or EMBRACE to the endpoint of EXTEND with 1 increase in MADRS total score >10 permitted.","definition_or_measurement_approach":"Sustained remission defined in-text as MADRS total score ≤10 with allowance of 1 increase in MADRS total score >10."}
• {"endpoint_text":"-Percentage of responders and remitters to 2 doses of IP administered in EXTEND who later relapse.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Change from Baseline to last visit in the total MADRS score in participants who did not respond to IP in APPROACH or EMBRACE","definition_or_measurement_approach":"Measured as change in total MADRS (Montgomery–Åsberg Depression Rating Scale) score from Baseline to last visit."}

Greece

Earliest CTIS Part Ii Submission Date

29-05-2025

Latest Decision Or Authorization Date

02-09-2025

Processing Time Days

96

Number Of Sites

3

Number Of Participants

21

Poland

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

08-09-2025

Processing Time Days

27

Number Of Sites

6

Number Of Participants

52

Ireland

Earliest CTIS Part Ii Submission Date

14-08-2025

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

22

Number Of Sites

2

Number Of Participants

10

Germany

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

09-01-2026

Processing Time Days

24

Number Of Sites

4

Number Of Participants

27

Czechia

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

17

Number Of Sites

3

Number Of Participants

21

Primary sponsor

Full Name

Cybin IRL Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Rosenbaum Research Greece M.E.P.E.

Responsibilities

local CRO performing the above selected duties in Greece only

Name

Worldwide Clinical Trials d.o.o.

Responsibilities

code: 1; code: 11; code: 12; code: 13; Data Surveillance (Rating Scales); code: 2; code: 5

Name

Block Clinical Inc.

Responsibilities

Patients’ Reimbursement

Name

Eresearchtechnology Inc.

Responsibilities

centralized ECG. Video/audio acquisition and storage

Name

Suvoda LLC

Responsibilities

code: 3 (quality assurance)

Third parties

• {"country":"United States","full_name":"Block Clinical Inc.","duties_or_roles":"Patients’ Reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"Rosenbaum Research Greece M.E.P.E.","duties_or_roles":"code: 1; code: 12; local CRO performing the above selected duties in Greece only","organisation_type":"Pharmaceutical company"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"code: 1; code: 11; code: 12; code: 13; Data Surveillance (Rating Scales); code: 2; code: 5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"centralized ECG. Video/audio acquisition and storage","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Apcer Life Sciences Limited","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"code: 6","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient facing material for engagement","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EMA Wellness LLC","duties_or_roles":"Electronic Patient Reported Outcomes (ePRO) / Electronic Clinical Outcome Assessment (eCOA)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fluence International Inc.","duties_or_roles":"Session monitor Vetting/Training","organisation_type":"Educational Institution"}
• {"country":"Switzerland","full_name":"BSI Business Systems Integration AG","duties_or_roles":"Clinical Trial Management Systems","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Eramol Limited","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}