RECRUITING

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

Conditions

Major Depressive Disorder MDD Psilocybin Psychedelic CYB003 Depression CYB003-002 Long-Term Extension CYB003-003

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)

Quick Facts

Study Start:2025-07-18

Study Completion:2028-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06605105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication * Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE * Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form * Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP * Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP * Female participants must have a negative pregnancy test at Baseline (the end of trial \[EOT\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day	* newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial * 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 * Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial * Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND * Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial * Positive urine test for drugs of abuse, or alcohol breath test prior to dosing. * Unwilling to consent to audio and video recording of psychological support and dosing sessions

Inclusion Criteria

Exclusion Criteria

* Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication
* Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE
* Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form
* Participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of IP
* Participants of childbearing potential (POCBP) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of IP
* Female participants must have a negative pregnancy test at Baseline (the end of trial \[EOT\] Visit in the APPROACH or EMBRACE trial), and prior to dose administration on the dosing day

* newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial
* 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
* Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the APPROACH or EMBRACE trial
* Presence of clinically significant ECG abnormalities noted during the APPROACH or EMBRACE trials or at the Baseline of EXTEND
* Sensitivity or suspected sensitivity to CYB003 noted in the APPROACH or EMBRACE trial
* Positive urine test for drugs of abuse, or alcohol breath test prior to dosing.
* Unwilling to consent to audio and video recording of psychological support and dosing sessions

Contacts and Locations

Study Contact

Clinical W Development

CONTACT

1-866-292-4601

clinicaltrialsinfo@cybin.com

Felix Mazer

CONTACT

Principal Investigator

Felix Mazer

STUDY_DIRECTOR

Cybin IRL Limited

Study Locations (Sites)

Research Centers of America

Hollywood, Florida, 33024

United States

Cenexel iResearcvh Atlanta, LLC

Atlanta, Georgia, 30030

United States

Collaborators and Investigators

Sponsor: Cybin IRL Limited

Felix Mazer, STUDY_DIRECTOR, Cybin IRL Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18

Study Completion Date2028-03-15

Study Record Updates

Study Start Date2025-07-18

Study Completion Date2028-03-15

Terms related to this study

Keywords Provided by Researchers

Major Depressive Disorder
MDD
Psilocybin
Psychedelic
CYB003
Depression
CYB003-002
Long-Term Extension
CYB003-003

Additional Relevant MeSH Terms

Major Depressive Disorder