BridgeMD
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
EU CTIS ID: 2024-516805-22-00
What this study is testing
To assess durability of response to IP after initial randomized, double-blind treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has successfully completed either the APPROACH or EMBRACE trial and received BOTH dose administrations of trial medication.
- Participant has continued the same antidepressant medication at the stable dose/day throughout the 12-week APPROACH or EMBRACE trial.
- 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.
- Participants can refrain from nicotine use during the dosing session (up to 8 hours).
- 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.
- 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.
You likely can't join if
- 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.
- 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).
- 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
- Clinical evidence of any new disease and/or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the IP.
- 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.
- 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
See the full eligibility criteria
Who can join
- Participant has successfully completed either the APPROACH or EMBRACE trial and received BOTH dose administrations of trial medication.
- Participant has continued the same antidepressant medication at the stable dose/day throughout the 12-week APPROACH or EMBRACE trial.
- 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.
- Participants can refrain from nicotine use during the dosing session (up to 8 hours).
- 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.
- 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.
- 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.
- 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
- Participant has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
What rules you out
- 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.
- 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).
- 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
- Clinical evidence of any new disease and/or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the IP.
- 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.
- 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
- 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
- Sensitivity or suspected sensitivity to IP noted in the APPROACH or EMBRACE trial
- 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
- Participants capable of producing sperm that are unable to abstain from sperm donation until 12 weeks after final dosing.
- 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
- 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.
- Any concern that participants may be at risk of developing serotonin syndrome with dosing of IP in the EXTEND trial
- Participant is unwilling to consent to audio and video recording of psychological support and dosing sessions
- Investigator’s decision that, for any reason, a participant may be unsuitable for enrollment.
- 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
- 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
- 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).
- Participants with renal insufficiency (eGFR ≤59 mL/min/1.73 m2).
- 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.
- Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.