A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (NCT06793397) | Clinical Trial Compass
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
United States330 participantsStarted 2025-12-10
Plain-language summary
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
Participants must meet all the following criteria to be included in the trial:
* Age18 to 85 years.
* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of ≥4 weeks and ≤24 months\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.
* Moderate to severe depression at Screening and Baseline, independently confirmed.
* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.
* Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.
* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).
* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.
* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.
* Part…
What they're measuring
1
Montgomery-Asberg Depression Scale (MADRS)
Timeframe: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.