A: CYB003 Both Medicine Sessions for Major Depressive Disorder (MDD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinilabs Drug Development Corporation, Eatontown, NJ
Major Depressive Disorder (MDD)+4 More
Psychotherapy - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in participants with major depressive disorder (MDD).

Eligible Conditions

  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Study Objectives

9 Primary · 8 Secondary · Reporting Duration: Screening

Day 56
Adverse Events
Day 22
5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Hallucinogen Rating Scale (HRS)
Holter monitoring
Mystical Experience Questionnaire (MEQ30)
Persisting Effects Questionnaire (PEQ)
VAS Ratings of "Any Drug Effect"
Day 23
Pharmacokinetic parameter of psilocin (AUC)
Pharmacokinetic parameter of psilocin (Cmax)
Resting 12 Lead ECG PR interval
Resting 12 Lead ECG QRS duration
Resting 12 Lead ECG QT interval
Resting 12 Lead ECG QTcF
Resting 12 Lead ECG ventricular rate
Day 38
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening
Day 56
Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV)
Screening
Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version

Trial Safety

Trial Design

2 Treatment Groups

A: CYB003 Both Medicine Sessions
1 of 2
B: Placebo in Medicine Session 1, CYB003 in Medicine Session 2
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: A: CYB003 Both Medicine Sessions · Has Placebo Group · Phase 1 & 2

A: CYB003 Both Medicine SessionsExperimental Group · 2 Interventions: Psychotherapy, CYB003 · Intervention Types: Behavioral, Drug
B: Placebo in Medicine Session 1, CYB003 in Medicine Session 2PlaceboComparator Group · 3 Interventions: Psychotherapy, Placebo, CYB003 · Intervention Types: Behavioral, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychotherapy
2008
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening
Closest Location: Clinilabs Drug Development Corporation · Eatontown, NJ
2020First Recorded Clinical Trial
2 TrialsResearching Major Depressive Disorder (MDD)
13 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
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.
You have been prescribed antidepressant medication for at least 6 months, and have not responded to the medication.
You are aged between 21 and 55 years, inclusive.\n
You have had an inadequate response to antidepressant medication in the past month.
You have given informed consent to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.