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Psychedelic
CYB003 for Major Depressive Disorder
Phase 1 & 2
Waitlist Available
Research Sponsored by Cybin IRL Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1, day 2, day 10, day 17, day 21, day 23, day 31, day 38, day 42, and day 56
Awards & highlights
Study Summary
This trial will study if an experimental drug is safe and tolerated by people with major depression.
Who is the study for?
This trial is for adults aged 21-55 with moderate to severe Major Depressive Disorder (MDD), who are generally healthy but have had an inadequate response to antidepressants. Participants must weigh at least 60 kg, not smoke, and have a BMI of 18-30 kg/m2. They cannot have treatment-resistant MDD or other major psychiatric conditions, be on certain medications, or pose any suicide risk.Check my eligibility
What is being tested?
The study tests the safety and tolerability of CYB003, a psilocybin analog given in ascending oral doses to healthy participants with and without MDD. It includes psychological support and psychotherapy sessions. Some participants will receive a placebo instead of CYB003 for comparison.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from similar substances include nausea, headache, dizziness, altered sensory experiences and mood changes. The study aims to identify any potential side effects from CYB003.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (All Arms)
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version (All Arms)
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV) (Arm E)
+20 moreSecondary outcome measures
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arm E)
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms A & B)
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) (Arms C & D)
+18 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: E: Healthy Volunteers - CYB003 in 3 of 3 Medicine SessionsExperimental Treatment2 Interventions
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.
Group II: C: Healthy Volunteers - CYB003 in 2 of 2 Medicine SessionsExperimental Treatment2 Interventions
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.
Group III: A: MDD Participants - CYB003 in 2 of 2 Medicine SessionsExperimental Treatment2 Interventions
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.
Group IV: B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2Placebo Group3 Interventions
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.
Group V: D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2Placebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CYB003
2022
Completed Phase 2
~60
Psychotherapy
2020
Completed Phase 3
~3120
Psychological Support
2022
Completed Phase 2
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Drug Safety NavigatorUNKNOWN
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Depression
36 Patients Enrolled for Depression
Clinilabs Drug Development CorporationUNKNOWN
Cybin IRL LimitedLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Depression
36 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are aged between 21 and 55 years, inclusive.\nYou have had an inadequate response to antidepressant medication in the past month.You have 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.Your current antidepressant medication is not working well for you, but you do not have treatment-resistant depression. A clinician will talk to you to confirm this.You have been diagnosed with certain mental health conditions such as schizophrenia, bipolar disorder, or personality disorder.You do not speak English fluently.You are currently taking certain medications for depression, psychosis, or mood stabilization.You have a history of brain disorders or conditions that can cause seizures or convulsions.Your personal circumstances or behavior could interfere with participation or may not be compatible with the study drug, as determined by the researcher.You have been diagnosed with a mental health condition according to the DSM-V guidelines.You have a high risk of wanting to harm yourself, as determined by a thorough mental health evaluation.You have another health condition that could affect the study results or make it unsafe for you to participate.You have been diagnosed with treatment-resistant depression, which means that you have tried two or more antidepressant medications at the right dose and for a long enough time, but they did not work for you.You have been diagnosed with high blood pressure or an irregular heartbeat.You have a medical condition that may affect how your body absorbs or processes the study drug.You have taken part in a medical study and received a medication or a new treatment within the past three months before starting this study.You have given informed consent to participate in this study.You have taken St. John's Wort or 5-hydroxytryptophan within 28 days before the study.
Research Study Groups:
This trial has the following groups:- Group 1: E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions
- Group 2: A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions
- Group 3: B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
- Group 4: C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions
- Group 5: D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05385783 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there presently any opportunities to partake in this experiment?
"Clinicaltrials.gov indicates that this investigation is currently searching for participants, with the trial initially posted on June 7th 2022 and recently edited on July 11th 2022."
Answered by AI
Which individuals are eligible for participation in this investigation?
"This clinical trial is searching for 40 patients, aged 21 to 55 and diagnosed with major depressive disorder (MDD), who match the following criteria: having a BMI between 18-30 kg/m2 at screening; being ≥60kg in weight; not smoking over the last 3 months as confirmed by urine cotinine test results; registered with a healthcare provider able to verify MDDs diagnosis and previous treatments of such; moderate or severe DSM-V certified MDD diagnosis through full psychiatric work up; inadequate response to current antidepressant medications without treatment resistance present according to diagnostic interview done by clinician. Additionally, participants must have been on stable dose"
Answered by AI
How many participants are being enrolled in this medical experiment?
"Affirmative. According to the details available on clinicaltrials.gov, this medical research is actively seeking patients since it was originally posted on July 6th 2022. Currently, 40 individuals are needed for a single site of the trial and its information has been recently edited as of July 11th 2022."
Answered by AI
What are the primary objectives of this research endeavor?
"Cybin IRL Limited, the sponsor of this experiment, has outlined Adverse Events as its primary outcome to be monitored over a Day 56 time frame. The secondary outcomes they will assess include the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC), Hallucinogen Rating Scale (HRS) and Persisting Effects Questionnaire (PEQ). The former consists of 94 items that are rated by subjects compared to their normal waking consciousness; HRS comprises 100 questions with an intensity scale ranging from 0 to 4; PEQ is composed of five queries measuring meaningfulness, spiritual significance, psychological insightfulness and"
Answered by AI
Are older adult patients eligible for participation in this trial?
"This clinical trial is only applicable to individuals between 21 and 55 years of age. Patients under 18 or over 65 have 405 and 1457 respective trials they can apply for."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
New York
New Jersey
Other
How old are they?
65+
18 - 65
What site did they apply to?
CenExel ACMR
iResearch Atlanta
Clinilabs Drug Development Corporation
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
Why did patients apply to this trial?
I’ve been diagnosed with Bipolar II and depression. Looking for an alternative to treat my depression. I'm taking 250 Mg of Zoloft, and 10 Mg of Wellbutrin.
PatientReceived 1 prior treatment
I turn to drugs and alcohol to treat my depression. It just makes it worse. The I attended rehab and my happiness is short lived. I return to my old ways as soon as I am discharged. The downward spiral begins again.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can my family visit me?
PatientReceived no prior treatments
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