The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
CYB003 is a synthetic psilocybin analog.
Manualized psychotherapy (called EMBARK) performed by facilitators
Placebo
CenExel ACMR
Atlanta, Georgia, United States
iResearch Atlanta
Decatur, Georgia, United States
Clinilabs Drug Development Corporation
Eatontown, New Jersey, United States
Adverse Events (All Arms)
Any untoward medical occurrence in a clinical investigation participant administered a drug and does not necessarily have a causal relationship with the treatment
Time frame: Day 1 thru End of Study Visit (which is: Day 56 Arms A & B; Day 28 Arms C & D; Day 35 Arms E)
Resting 12 Lead ECG ventricular rate (Arms A & B)
ventricular rate (beats per minute)
Time frame: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, & Day 23
Resting 12 Lead ECG ventricular rate (Arms C & D)
ventricular rate (beats per minute)
Time frame: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG ventricular rate (Arms E)
ventricular rate (beats per minute)
Time frame: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG PR interval (Arms A & B)
PR interval (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG PR interval (Arms C & D)
PR interval (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG PR interval (Arms E)
PR interval (milliseconds)
Time frame: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QRS duration (Arms A & B)
QRS duration (milliseconds)
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Manualized psychological support performed by facilitators
Time frame: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QRS duration (Arms C & D)
QRS duration (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QRS duration (Arms E)
QRS duration (milliseconds)
Time frame: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QT interval (Arms A & B)
QT interval (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QT interval (Arms C & D)
QT interval (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QT interval (Arms E)
QT interval (milliseconds)
Time frame: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Resting 12 Lead ECG QTcF (Arms A & B)
Corrected QT interval by Fredericia (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Resting 12 Lead ECG QTcF (Arms C & D)
Corrected QT interval by Fredericia (milliseconds)
Time frame: Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Resting 12 Lead ECG QTcF (Arms E)
Corrected QT interval by Fredericia (milliseconds)
Time frame: Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Holter monitoring (Arms A & B)
Record of the electrical activity of the heart (Hz)
Time frame: Day -1, Day 1, Day 22
Holter monitoring (Arms C & D)
Record of the electrical activity of the heart (Hz)
Time frame: Day -1, Day 1, Day 8
Holter monitoring (Arm E)
Record of the electrical activity of the heart (Hz)
Time frame: Day -1, Day 1, Day 8, Day 15
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version (All Arms)
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).
Time frame: Screening
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms A & B)
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).
Time frame: Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 38, Day 42, and Day 56
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms C & D)
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).
Time frame: Day -1, Day 2, Day 7, Day 9, Day 15, Day 21, Day 28
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arm E)
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).
Time frame: Day -1, Day 2, Day 7, Day 9, Day 14, Day 16, Day 21, Day 28, Day 35
Mystical Experience Questionnaire (MEQ30) (Arms A & B)
The revised MEQ30 consists of 30 questions looking back on the entirety of a medicine session, participants are asked to answer each question according to one's feelings, thoughts, and experiences at the time of the session. Each item is rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The minimum score is 0 and the maximum score is 150 with higher scores indicating a greater degree of mystical experience. The MEQ total score is computed by taking the average response to all items.
Time frame: Day 1 & Day 22
Mystical Experience Questionnaire (MEQ30) (Arms C & D)
The revised MEQ30 consists of 30 questions looking back on the entirety of a medicine session, participants are asked to answer each question according to one's feelings, thoughts, and experiences at the time of the session. each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The minimum score is 0 and the maximum score is 150 with higher scores indicating a greater degree of mystical experience. The MEQ total score is computed by taking the average response to all items.
Time frame: Day 1 & Day 8
Mystical Experience Questionnaire (MEQ30) (Arms C & D)
The revised MEQ30 consists of 30 questions looking back on the entirety of a medicine session, participants are asked to answer each question according to one's feelings, thoughts, and experiences at the time of the session. each item rated on a Likert scale (0-None/not at all to 5-Extreme, more than any other time in my life). The minimum score is 0 and the maximum score is 150 with higher scores indicating a greater degree of mystical experience. The MEQ total score is computed by taking the average response to all items.
Time frame: Day 1, Day 8, & Day 15
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms A & B)
The 5D-ASC consists of a set of 94 items that participants are asked to rate to what extent the statements apply to one's particular experience, compared to normal waking consciousness. This has 11 subscales and higher scores are indicative of good outcomes.
Time frame: Day 1 & Day 22
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms C & D)
The 5D-ASC consists of a set of 94 items that participants are asked to rate to what extent the statements apply to one's particular experience, compared to normal waking consciousness. This has 11 subscales and higher scores are indicative of good outcomes.
Time frame: Day 1 & Day 8
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arm E)
The 5D-ASC consists of a set of 94 items that participants are asked to rate to what extent the statements apply to one's particular experience, compared to normal waking consciousness. This has 11 subscales and higher scores are indicative of good outcomes.
Time frame: Day 1, Day 8, & Day 15
Hallucinogen Rating Scale (HRS) (Arms A & B)
The HRS is a questionnaire with up to 100 items and is designed to assess the subjective effects of hallucinogenic substances. Responses to the majority of questions are on a 5 point intensity scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; and 4=extremely. Some questions have a slightly modified scale, and one question asks to rate the amount of time between when the drug was administered and feeling an effect from: no effect, 0 5 minutes, 5-15 minutes, 15-30 minutes, 30 60 minutes, or more than one hour. The minimum score is zero and maximum score is 400 with higher scores indicating greater hallucinogenic effect.
Time frame: Day 1 & Day 22
Hallucinogen Rating Scale (HRS) (Arms C & D)
The HRS is a questionnaire with up to 100 items and is designed to assess the subjective effects of hallucinogenic substances. Responses to the majority of questions are on a 5 point intensity scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; and 4=extremely. Some questions have a slightly modified scale, and one question asks to rate the amount of time between when the drug was administered and feeling an effect from: no effect, 0 5 minutes, 5-15 minutes, 15-30 minutes, 30 60 minutes, or more than one hour. The minimum score is zero and maximum score is 400 with higher scores indicating greater hallucinogenic effect.
Time frame: Day 1 & Day 8
Hallucinogen Rating Scale (HRS) (Arm E)
The HRS is a questionnaire with up to 100 items and is designed to assess the subjective effects of hallucinogenic substances. Responses to the majority of questions are on a 5 point intensity scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; and 4=extremely. Some questions have a slightly modified scale, and one question asks to rate the amount of time between when the drug was administered and feeling an effect from: no effect, 0 5 minutes, 5-15 minutes, 15-30 minutes, 30 60 minutes, or more than one hour. The minimum score is zero and maximum score is 400 with higher scores indicating greater hallucinogenic effect.
Time frame: Day 1, Day 8, & Day 15
Persisting Effects Questionnaire (PEQ) (Arms A & B)
The PEQ is a 5-item questionnaire that assesses the meaningfulness, spiritual significance, psychological insightfulness, and how psychologically challenging a participant experience was during the medicine session. Scores are assessed on a scale from 0 (not at all) to 5 (extremely). Higher scores (under consideration of reverse-scored items) indicate stronger persisting treatment effects.
Time frame: Day 1 & Day 22
Persisting Effects Questionnaire (PEQ) (Arms C & D)
The PEQ is a 5-item questionnaire that assesses the meaningfulness, spiritual significance, psychological insightfulness, and how psychologically challenging a participant experience was during the medicine session. Scores are assessed on a scale from 0 (not at all) to 5 (extremely). Higher scores (under consideration of reverse-scored items) indicate stronger persisting treatment effects.
Time frame: Day 1 & Day 8
Persisting Effects Questionnaire (PEQ) (Arm E)
The PEQ is a 5-item questionnaire that assesses the meaningfulness, spiritual significance, psychological insightfulness, and how psychologically challenging a participant experience was during the medicine session. Scores are assessed on a scale from 0 (not at all) to 5 (extremely). Higher scores (under consideration of reverse-scored items) indicate stronger persisting treatment effects.
Time frame: Day 1, Day 8, & Day 15
VAS Ratings of "Any Drug Effect" (Arms A & B)
The visual analog scale (VAS) for "Any Drug Effect" consists of a 100mm bipolar line with the far-left side of the line marked "not at all" and the far-right side of the line marked "extremely" to assess if participants feel any drug effect.
Time frame: Day 1 & Day 22
VAS Ratings of "Any Drug Effect" (Arms C & D)
The visual analog scale (VAS) for "Any Drug Effect" consists of a 100mm bipolar line with the far-left side of the line marked "not at all" and the far-right side of the line marked "extremely" to assess if participants feel any drug effect.
Time frame: Day 1 & Day 8
VAS Ratings of "Any Drug Effect" (Arm E)
The visual analog scale (VAS) for "Any Drug Effect" consists of a 100mm bipolar line with the far-left side of the line marked "not at all" and the far-right side of the line marked "extremely" to assess if participants feel any drug effect.
Time frame: Day 1, Day 8, & Day 15
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening (Arms A & B)
The minimum and maximum values are 0 and 60 with a higher score indicating a worse outcome.
Time frame: Screening, Day -1, Day 1, Day 10, Day 17, Day 31, & Day 38
Pharmacokinetic parameter of psilocin (Cmax) (Arms A & B)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Time frame: Day 1, Day 2, Day 22, & Day 23
Pharmacokinetic parameter of psilocin (Cmax) (Arms C & D)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Time frame: Day 1, Day 2, Day 8, & Day 9
Pharmacokinetic parameter of psilocin (Cmax) (Arm E)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Time frame: Day 1, Day 2, Day 8, Day 9, Day 15, & Day 16
Pharmacokinetic parameter of psilocin (AUC) (Arms A & B)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Time frame: Day 1, Day 2, Day 22, & Day 23
Pharmacokinetic parameter of psilocin (AUC) (Arms C & D)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Time frame: Day 1, Day 2, Day 8, & Day 9
Pharmacokinetic parameter of psilocin (AUC) (Arm E)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Time frame: Day 1, Day 2, Day 8, Day 9, Day 15, & Day 16