Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• CYB003 — DRUG
  CYB003 is a deuterated psilocin analog

Study Details

This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

Key Dates

First listed

Sep 20, 2024

Start date

Jul 18, 2025

Status verified

Sep 2026

Primary completion

Mar 15, 2028

Completion

Mar 15, 2028

Study Design

Enrollment

468 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CYB003
  Initial non-responders in CYB003-002 APPROACH and CYB003-003 EMBRACE, or initial responders who later relapse will be eligible to receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. If a participant relapses again, the participant may receive an additional single 16mg of CYB003 (maximum of 3 16mg doses in CYB003-004 EXTEND). Participants will continue on their current antidepressants and receive psychological support throughout the study.

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, Day 28, Day 56, Day 84, Day 112, Day 140, Day 168, Day 196, Day 244, Day 252, Day 280, Day 301; additional assessments at Day -15, Day -1, Day 2, Day 10, Day 17, Day 21, Day 23, Day 31, Day 42 if non-response or relapse criteria met ]

Locations (42)

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