"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" (APPROACH)
A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder
Sponsor: Cybin IRL Limited
Listed as NCT06564818, this observational or N/A phase trial focuses on Major Depressive Disorder and remains actively recruiting participants. Sponsored by Cybin IRL Limited, it has been updated 13 times since 2024, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
13 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE3
▶ Show 8 earlier versions
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Oct 2025 — Dec 2025 [monthly]
Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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May 2025 — Aug 2025 [monthly]
Recruiting PHASE3
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE3
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Dec 2024 — Mar 2025 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2024 — Dec 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.
Contact Information
- Cybin IRL Limited
For direct contact, visit the study record on ClinicalTrials.gov .