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

Phase 3

Not yet recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: CYB003

• Registration Number: NCT06605105
• Lead Sponsor: Cybin IRL Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20
• Study Start: 2025-02-23
• Primary Completion: 2027-09-06
• Study Completion: 2027-09-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Has met all the entry criteria for CYB003-002 APPROACH.
• Has successfully completed CYB003-002 APPROACH. Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

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Exclusion Criteria

• Meets any of the exclusion criteria for CYB003-002 APPROACH.
• Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation/attempt or self-harm in CYB003-002 APPROACH OR has had a >1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH.
• Positive urine test for drugs of abuse, cannabis, or alcohol breath test prior to dosing.
• Unwilling to consent to audio and video recording of psychological support and dosing sessions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CYB003	CYB003	Initial non-responders in CYB003-002 APPROACH 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 Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	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	The MADRS is a 10-item scale with ratings based on a clinical interview which moves from broadly phrased questions about symptoms to more detailed ones allowing a precise rating of severity.