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Psychedelic

CYB003 for Depression

iResearch Atlanta, Decatur, GA
CYB003 +3 morePhase 1 & 2RecruitingResearch Sponsored by Cybin IRL Limited

Study Summary

This trial will study if an experimental drug is safe and tolerated by people with major depression.

Eligible Conditions
  • Depression

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with certain mental health conditions such as schizophrenia, bipolar disorder, or personality disorder.
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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.
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You have been diagnosed with a mental health condition according to the DSM-V guidelines.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1, day 2, day 10, day 17, day 21, day 23, day 31, day 38, day 42, and day 56 for reporting.

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 more
Secondary 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 more

Trial 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
Psychotherapy
2014
Completed Phase 3
~3050

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Clinilabs Drug Development CorporationUNKNOWN
Drug Safety NavigatorUNKNOWN
Cybin IRL LimitedLead Sponsor
Amir Inamdar, MBBS,DNB,MFPMStudy Director
Cybin IRL Limited

Media Library

CYB003 (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05385783 — Phase 1 & 2
Depression Research Study Groups: C: Healthy Volunteers - CYB003 in 2 of 2 Medicine Sessions, E: Healthy Volunteers - CYB003 in 3 of 3 Medicine Sessions, A: MDD Participants - CYB003 in 2 of 2 Medicine Sessions, B: MDD Participants - Placebo in Medicine Session 1, CYB003 in Medicine Session 2, D: Healthy Volunteers - Placebo in Medicine Session 1, CYB003 in Medicine Session 2
Depression Clinical Trial 2023: CYB003 Highlights & Side Effects. Trial Name: NCT05385783 — Phase 1 & 2
CYB003 (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05385783 — Phase 1 & 2
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?
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+

What questions have other patients asked about this trial?

Can my family visit me?
Patient

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.
Patient
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.
Patient
Recent research and studies
clinicaltrials.govStudy
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
2022. "A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05385783.
~5 spots leftby Oct 2023
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