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A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CYB003
Psychotherapy
Placebo
Psychological Support
Sponsored by
Cybin IRL Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, Psilocybin, Psychedelic, Psilocin, CYB003, CYB003-001, Depression, Healthy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Has a diagnosis of MDD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-V] of moderate to severe degree), established through a full psychiatric work up, who are otherwise healthy.
  • Inadequate response to current antidepressant medication, and absence of treatment- resistant depression, based on a diagnostic interview conducted by a clinician.
  • Aged between 21 to 55 years, inclusive, at Screening.
  • Has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
  • Is ≥60 kg.
  • A non-smoker for at least the past 3 months with a negative urine cotinine test at Screening.
  • Has been on a stable dose of antidepressant medication (no more than 50% change) in the last month prior to Screening and has had an inadequate response, as judged by the Investigator.
  • Registered with a healthcare professional who can confirm the diagnosis and previous treatments received by the participant.
  • Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder.
  • Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview.
  • Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments given at an adequate dose for an adequate duration.
  • Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, an antipsychotic or a mood stabilizer.
  • Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
  • Diagnosis of hypertension or an arrhythmia.
  • History of hypothyroidism and/or current abnormal thyroid function tests.
  • Clinically relevant abnormal laboratory results.
  • Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to the study drug), as judged by the Investigator.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
  • Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
  • Has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).
  • Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti- HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
  • Has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.
  • Use of a prescription medicine (except for stable chronic dose of antidepressant medication(s), sedatives/hypnotics, and hormonal contraceptives, if applicable), certain herbal supplements (to be reviewed by the Investigator), or over-the-counter (OTC) medicine, during the 28 days before dosing. Stable chronic therapy with hormone replacement medication is also allowed. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
  • Donation of blood or plasma of >400 mL within 1 month prior to first dosing until 4 weeks after final dosing.
  • Is pregnant, breastfeeding or planning to conceive.
  • Known difficulty with obtaining intravenous access.

Sites / Locations

  • CenExel ACMRRecruiting
  • iResearch AtlantaRecruiting
  • Clinilabs Drug Development Corporation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions

B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2

C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions

D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2

E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
Resting 12 Lead ECG ventricular rate (Arms A & B)
ventricular rate (beats per minute)
Resting 12 Lead ECG ventricular rate (Arms C & D)
ventricular rate (beats per minute)
Resting 12 Lead ECG ventricular rate (Arms E)
ventricular rate (beats per minute)
Resting 12 Lead ECG PR interval (Arms A & B)
PR interval (milliseconds)
Resting 12 Lead ECG PR interval (Arms C & D)
PR interval (milliseconds)
Resting 12 Lead ECG PR interval (Arms E)
PR interval (milliseconds)
Resting 12 Lead ECG QRS duration (Arms A & B)
QRS duration (milliseconds)
Resting 12 Lead ECG QRS duration (Arms C & D)
QRS duration (milliseconds)
Resting 12 Lead ECG QRS duration (Arms E)
QRS duration (milliseconds)
Resting 12 Lead ECG QT interval (Arms A & B)
QT interval (milliseconds)
Resting 12 Lead ECG QT interval (Arms C & D)
QT interval (milliseconds)
Resting 12 Lead ECG QT interval (Arms E)
QT interval (milliseconds)
Resting 12 Lead ECG QTcF (Arms A & B)
Corrected QT interval by Fredericia (milliseconds)
Resting 12 Lead ECG QTcF (Arms C & D)
Corrected QT interval by Fredericia (milliseconds)
Resting 12 Lead ECG QTcF (Arms E)
Corrected QT interval by Fredericia (milliseconds)
Holter monitoring (Arms A & B)
Record of the electrical activity of the heart (Hz)
Holter monitoring (Arms C & D)
Record of the electrical activity of the heart (Hz)
Holter monitoring (Arm E)
Record of the electrical activity of the heart (Hz)
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pharmacokinetic parameter of psilocin (Cmax) (Arms A & B)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Pharmacokinetic parameter of psilocin (Cmax) (Arms C & D)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Pharmacokinetic parameter of psilocin (Cmax) (Arm E)
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Pharmacokinetic parameter of psilocin (AUC) (Arms A & B)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Pharmacokinetic parameter of psilocin (AUC) (Arms C & D)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Pharmacokinetic parameter of psilocin (AUC) (Arm E)
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.

Full Information

First Posted
May 10, 2022
Last Updated
August 9, 2023
Sponsor
Cybin IRL Limited
Collaborators
Clinilabs Drug Development Corporation, Drug Safety Navigator
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1. Study Identification

Unique Protocol Identification Number
NCT05385783
Brief Title
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
Official Title
A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Relative Bioavailability and Food Effect Cohort to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of CYB003 in Healthy Participants With and Without Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
January 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cybin IRL Limited
Collaborators
Clinilabs Drug Development Corporation, Drug Safety Navigator

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD, Psilocybin, Psychedelic, Psilocin, CYB003, CYB003-001, Depression, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CYB003
Intervention Description
CYB003 is a synthetic psilocybin analog.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Manualized psychotherapy (called EMBARK) performed by facilitators
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Psychological Support
Intervention Description
Manualized psychological support performed by facilitators
Primary Outcome Measure Information:
Title
Adverse Events (All Arms)
Description
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)
Title
Resting 12 Lead ECG ventricular rate (Arms A & B)
Description
ventricular rate (beats per minute)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 21, Day 22, & Day 23
Title
Resting 12 Lead ECG ventricular rate (Arms C & D)
Description
ventricular rate (beats per minute)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Title
Resting 12 Lead ECG ventricular rate (Arms E)
Description
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
Title
Resting 12 Lead ECG PR interval (Arms A & B)
Description
PR interval (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Title
Resting 12 Lead ECG PR interval (Arms C & D)
Description
PR interval (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Title
Resting 12 Lead ECG PR interval (Arms E)
Description
PR interval (milliseconds)
Time Frame
Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Title
Resting 12 Lead ECG QRS duration (Arms A & B)
Description
QRS duration (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Title
Resting 12 Lead ECG QRS duration (Arms C & D)
Description
QRS duration (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Title
Resting 12 Lead ECG QRS duration (Arms E)
Description
QRS duration (milliseconds)
Time Frame
Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Title
Resting 12 Lead ECG QT interval (Arms A & B)
Description
QT interval (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Title
Resting 12 Lead ECG QT interval (Arms C & D)
Description
QT interval (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Title
Resting 12 Lead ECG QT interval (Arms E)
Description
QT interval (milliseconds)
Time Frame
Screening, Day -1, Day1, Day 2, Day 7, Day 8, Day 9, Day 14, Day 15, Day 16
Title
Resting 12 Lead ECG QTcF (Arms A & B)
Description
Corrected QT interval by Fredericia (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 21, Day 22, Day 23
Title
Resting 12 Lead ECG QTcF (Arms C & D)
Description
Corrected QT interval by Fredericia (milliseconds)
Time Frame
Screening, Day -1, Day 1, Day 2, Day 7, Day 8, & Day 9
Title
Resting 12 Lead ECG QTcF (Arms E)
Description
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
Title
Holter monitoring (Arms A & B)
Description
Record of the electrical activity of the heart (Hz)
Time Frame
Day -1, Day 1, Day 22
Title
Holter monitoring (Arms C & D)
Description
Record of the electrical activity of the heart (Hz)
Time Frame
Day -1, Day 1, Day 8
Title
Holter monitoring (Arm E)
Description
Record of the electrical activity of the heart (Hz)
Time Frame
Day -1, Day 1, Day 8, Day 15
Title
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version (All Arms)
Description
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
Title
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms A & B)
Description
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
Title
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arms C & D)
Description
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
Title
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arm E)
Description
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
Secondary Outcome Measure Information:
Title
Mystical Experience Questionnaire (MEQ30) (Arms A & B)
Description
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
Title
Mystical Experience Questionnaire (MEQ30) (Arms C & D)
Description
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
Title
Mystical Experience Questionnaire (MEQ30) (Arms C & D)
Description
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
Title
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms A & B)
Description
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
Title
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms C & D)
Description
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
Title
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arm E)
Description
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
Title
Hallucinogen Rating Scale (HRS) (Arms A & B)
Description
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
Title
Hallucinogen Rating Scale (HRS) (Arms C & D)
Description
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
Title
Hallucinogen Rating Scale (HRS) (Arm E)
Description
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
Title
Persisting Effects Questionnaire (PEQ) (Arms A & B)
Description
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
Title
Persisting Effects Questionnaire (PEQ) (Arms C & D)
Description
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
Title
Persisting Effects Questionnaire (PEQ) (Arm E)
Description
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
Title
VAS Ratings of "Any Drug Effect" (Arms A & B)
Description
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
Title
VAS Ratings of "Any Drug Effect" (Arms C & D)
Description
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
Title
VAS Ratings of "Any Drug Effect" (Arm E)
Description
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
Title
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening (Arms A & B)
Description
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
Title
Pharmacokinetic parameter of psilocin (Cmax) (Arms A & B)
Description
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Time Frame
Day 1, Day 2, Day 22, & Day 23
Title
Pharmacokinetic parameter of psilocin (Cmax) (Arms C & D)
Description
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data.
Time Frame
Day 1, Day 2, Day 8, & Day 9
Title
Pharmacokinetic parameter of psilocin (Cmax) (Arm E)
Description
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
Title
Pharmacokinetic parameter of psilocin (AUC) (Arms A & B)
Description
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
Title
Pharmacokinetic parameter of psilocin (AUC) (Arms C & D)
Description
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
Title
Pharmacokinetic parameter of psilocin (AUC) (Arm E)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria - MDD & Healthy Volunteer Participants: Aged between 21 to 65 years, inclusive, at Screening. Has a BMI of 18 to 30 kg/m2, inclusive, at Screening. Is ≥60 kg. Is negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at Screening and at Day -1. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Additional Inclusion Criteria - MDD Participants Only: Has a diagnosis of MDD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-V] of moderate to severe degree), established through a full psychiatric work up, who are otherwise healthy. Has been on a stable dose of antidepressant medication (no more than 50% change) in the last month prior to Screening and has had an inadequate response, as judged by the Investigator. Exclusion Criteria - MDD & Healthy Volunteer Participants: Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview. Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder). Diagnosis of hypertension or an arrhythmia. History of hypothyroidism and/or current abnormal thyroid function tests. Clinically relevant abnormal laboratory results. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study. Not fluent in the English language. Has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions). Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti- HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening. Has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication. Is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to receiving the study drug. Is taking or has taken over the counter (OTC) doses of 5-hydroxytrptophan or St John's Wort within 28 days prior to receiving the study drug. Donation of blood or plasma of >400 mL within 1 month prior to first dosing until 4 weeks after final dosing. Is pregnant, breastfeeding or planning to conceive. Known difficulty with obtaining intravenous access. Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to the study drug), as judged by the Investigator. Additional Exclusion Criteria - Healthy Volunteers Only: Current or previously diagnosed with a mental health disorder as defined by DSM-V criteria. Use of any prescription medicine (except for hormonal contraceptives, if applicable), certain herbal supplements (to be reviewed by the Investigator), or OTC medicine during the 28 days before dosing. Additional Exclusion Criteria - MDD Participants Only: Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments given at an adequate dose for an adequate duration. Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, an antipsychotic or a mood stabilizer. Use of a prescription medicine (except participants may take a stable chronic dose of antidepressant medication(s) and/or sedatives/hypnotics, and may take hormonal contraceptives, if applicable), certain herbal supplements (to be reviewed by the Investigator), or OTC medicine during the 28 days before dosing (some exceptions apply).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Recruitment Manager
Phone
404-537-1281
Email
k.prowse@cenexel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Inamdar, MBBS,DNB,MFPM
Organizational Affiliation
Cybin IRL Limited
Official's Role
Study Director
Facility Information:
Facility Name
CenExel ACMR
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Prowse
Phone
404-537-1281
Email
k.prowse@cenexel.com
First Name & Middle Initial & Last Name & Degree
Maria Johnson, MD
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Prowse
Phone
404-537-1281
Email
k.prowse@cenexel.com
First Name & Middle Initial & Last Name & Degree
Saundra A Maass-Robinson, MD
Facility Name
Clinilabs Drug Development Corporation
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://depressionpsychedelicstudy.com
Description
New Jersey Site Recruitment Website. Please click on link to apply

Learn more about this trial

A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

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