CYB003 / Depression Major Depressive Disorder / Depression in Adults · Phase 3 Trial

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 registration for a randomized, placebo-controlled trial of CYB003 (a deuterated psilocin analog) as adjunctive treatment in major depressive disorder. No results are posted in this registry record; the trial is currently recruiting and has not yet reported outcomes.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression; age from 18 Years; to 85 Years. Intervention: Experimental Arm A CYB003 in 2 of 2 Dosing Sessions; Experimental Arm B CYB003 in 2 of 2 Dosing Sessions. Compared with: Placebo Comparator: Arm C Placebo in 2 of 2 Dosing Session — Placebo Comparator. n = 330. 68 sites across 8 countries.

Key findings

Safety

This is a trial registration with no results posted; no efficacy, safety, or tolerability data are available for assessment.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 registration with no posted results; the trial is actively recruiting and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Montgomery-Asberg Depression Scale (MADRS) (assessed at Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Tr…)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationMajor Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression; age from 18 Years; to 85 Years

Sample size330

InterventionExperimental Arm A CYB003 in 2 of 2 Dosing Sessions; Experimental Arm B CYB003 in 2 of 2 Dosing Sessions

ComparatorPlacebo Comparator: Arm C Placebo in 2 of 2 Dosing Session — Placebo Comparator

Setting68 sites across 8 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment330

Primary outcome measureMontgomery-Asberg Depression Scale (MADRS)

Planned assessment timepointsScreening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63, Day 84/End of Trial

Caveats

This is a trial registration with no results posted; no efficacy, safety, or tolerability data are available for assessment.
Randomization method, blinding status, and allocation concealment procedures are not described in this registry record.
No baseline characteristics, inclusion/exclusion criteria detail, or comparator arm specification are provided.
Follow-up duration and analysis plan are not fully specified in the registry text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial with placebo comparator.

Directness

strong

Primary outcome is MADRS, a validated clinical depression scale.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study is ongoing; no methodology detail provided for blinding, allocation concealment assessment.

Sample adequacy

moderate

Planned enrollment 330 participants; adequacy depends on effect size assumptions not stated here.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06793397). This is a study registration, not published results. Lead sponsor: Cybin IRL Limited. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 330 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression. Interventions: DRUG: CYB003; BEHAVIORAL: Psychological Support. Primary outcome measures: Montgomery-Asberg Depression Scale (MADRS) , Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.. Brief 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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Cybin IRLCYB003Depression Major Depressive DisorderDepression in AdultsNCT06793397Major Depressive Disorder (MDD)Psychological Support