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ENROLLING BY INVITATION

NCT06605105

PHASE3

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

Sponsor: Cybin IRL Limited

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

468

Start Date

2025-07-18

Completion Date

2028-06-06

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Major Depressive Disorder

Interventions

DRUG

CYB003

CYB003 is a deuterated psilocin analog

Inclusion 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 Exclusion Criteria: * 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

Locations (49)

Scottsdale Research Institute

Phoenix, Arizona, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Kadima Neuropsychiatry Institute

La Jolla, California, United States

TRIP Clinic and Psychedelic Science Institute

Los Angeles, California, United States

CalNeuro Research Group

Los Angeles, California, United States

Lipov Medical Group

Los Angeles, California, United States

Excell Research, Inc

Oceanside, California, United States

Open Mind Collective / UCSF Medical Center - Mount Zion

San Francisco, California, United States

Inland Psychiatric Medical Group Inc (IPMG Research)

San Juan Capistrano, California, United States

Mountain View Clinical Research

Denver, Colorado, United States

Starlight Clinical Research

Evergreen, Colorado, United States

Research Centers of America

Hollywood, Florida, United States

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

K2 Medical Research

Lady Lake, Florida, United States

Segal Trials Center for Psychedelic Research

Lauderhill, Florida, United States

Accel Research Sites - Maitland

Maitland, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Charter Research

Orlando, Florida, United States

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Cenexel iResearcvh Atlanta, LLC

Atlanta, Georgia, United States

Atlanta Center For Medical Research

Atlanta, Georgia, United States

CenExel iResearch

Savannah, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Psychiatric Medicine Associates, LLC

Skokie, Illinois, United States

Psychiatric Medicine Associates

Skokie, Illinois, United States

Sunstone Medical, PC

Rockville, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Elixia Health

Springfield, Massachusetts, United States

Adams Clinical

Watertown, Massachusetts, United States

Institute for Integrative Therapies

Eden Prairie, Minnesota, United States

Redbird Research

Las Vegas, Nevada, United States

Global Medical Institutes, Princeton Medical Institute

Princeton, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Adams Clinical Harlem

New York, New York, United States

Adams Clinical Bronx

The Bronx, New York, United States

Neurobehavioral Clinical Research

Canton, Ohio, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Clinical Neuroscience Solutions, CNS Healthcare

Memphis, Tennessee, United States

Adams Clinical Dallas

DeSoto, Texas, United States

Zillan Clinical Research

Houston, Texas, United States

Cedar Clinical Research

Draper, Utah, United States

Thompson Brain & Mind Healthcare

Maroochydore, Queensland, Australia

Ramsay Clinic

Melbourne, Victoria, Australia

Monash University - Notting Hill

Notting Hill, Victoria, Australia

Eginition Hospital, First Department of Psychiatry of the National and Kapodistrian University of Athens (NKUA)

Athens, Greece

Aristotle University of Tessaloniki

Thessaloniki, Greece

Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy

Bydgoszcz, Poland

Ascend Clinical Research

Reading, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)