Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CYB003 · 4 trials · 7 indications
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phased questions about symptoms to more detailed ones allowing a precise rating of severity. The total score ranges 0-60, higher scores denote greater severity.
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity. The scale consists of ten items rated on a scale from 0 to 6, resulting in a total score ranging from 0 (normal / symptom absent) to 60 (severe depression).
The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity.
Any untoward medical occurrence in a clinical investigation participant administered a drug and does not necessarily have a causal relationship with the treatment
ventricular rate (beats per minute)
ventricular rate (beats per minute)
ventricular rate (beats per minute)
PR interval (milliseconds)
PR interval (milliseconds)
PR interval (milliseconds)
QRS duration (milliseconds)
QRS duration (milliseconds)
QRS duration (milliseconds)
QT interval (milliseconds)
QT interval (milliseconds)
QT interval (milliseconds)
Corrected QT interval by Fredericia (milliseconds)
Corrected QT interval by Fredericia (milliseconds)
Corrected QT interval by Fredericia (milliseconds)
Record of the electrical activity of the heart (Hz)
Record of the electrical activity of the heart (Hz)
Record of the electrical activity of the heart (Hz)
Evaluation tool that evaluates a lifetime history of suicidal ideation and/or behavior. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
Evaluation tool that evaluates risk for suicide since the last study visit. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).
| Arm | Type | Description |
|---|---|---|
| Experimental Arm A CYB003 in 2 of 2 Dosing Sessions | EXPERIMENTAL | Arm A participants will receive 8 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study. |
| Experimental Arm B CYB003 in 2 of 2 Dosing Sessions | EXPERIMENTAL | Experimental Arm B participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. |
| Placebo Comparator: Arm C Placebo in 2 of 2 Dosing Session | PLACEBO_COMPARATOR | Participants will receive placebo in 2 of 2 medicine sessions, approximately three weeks apart. All Arm C participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial. |
| CYB003 | EXPERIMENTAL | Initial non-responders in CYB003-002 APPROACH and CYB003-003 EMBRACE, or initial responders who later relapse will be eligible to receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. If a participant relapses again, the participant may receive an additional single 16mg of CYB003 (maximum of 3 16mg doses in CYB003-004 EXTEND). Participants will continue on their current antidepressants and receive psychological support throughout the study. |
| Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions | EXPERIMENTAL | Arm A participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study. |
| Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions | PLACEBO_COMPARATOR | Arm B participants will receive placebo in 2 of 2 Dosing Sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial. |
| A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions | EXPERIMENTAL | Arm A MDD participants will receive CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study. |
| B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2 | PLACEBO_COMPARATOR | Arm B MDD participants will receive placebo in Medicine Session 1, and approximately three weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All MDD participants will receive supportive EMBARK psychotherapy throughout the study. |
| C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions | EXPERIMENTAL | Arm C healthy volunteers will receive CYB003 in 2 of 2 medicine sessions, approximately one to two weeks apart. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study. |
| D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2 | PLACEBO_COMPARATOR | Arm D healthy volunteers will receive placebo in Medicine Session 1, and approximately one to two weeks later will receive CYB003 in Medicine Session 2. The CYB003 dose received will depend on the cohort/time of enrollment. All healthy volunteers will receive psychological support throughout the study. |
| E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions | EXPERIMENTAL | Arm E healthy volunteers will receive CYB003 in 3 of 3 medicine sessions, approximately one week apart from each other, to assess bioavailability and food effect. The CYB003 dose received will depend on the safety review committee selection/time of enrollment. All healthy volunteers will receive psychological support throughout the study. |
| Name | Type | Description |
|---|---|---|
| CYB003 | DRUG | CYB003 is a deuterated psilocin analog. |
| Psychological Support | BEHAVIORAL | Manualized psychological support performed by facilitator. |
| Placebo | DRUG | Placebo |
| Psychotherapy | BEHAVIORAL | Manualized psychotherapy (called EMBARK) performed by facilitators |
Inclusion Criteria: Participants must meet all the following criteria to be included in the trial: * Age18 to 85 years. * Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of ≥4 weeks and ≤24 months\] and established as per evaluat...
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