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Enrolling by invitationPhase 3

Long-term safety study of CYB003 in adults with major depression

Tests CYB003 over the long term in adults with major depressive disorder.

Plain-language title generated from the registry record
Registry title: Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

Key facts

Where
Atlanta, Boston, Canton, Chicago, Denver, DeSoto, Draper, Eden Prairie, Evergreen, Glendale, Hollywood, Houston, Jacksonville, La Jolla, Lady Lake, Las Vegas, Lauderhill, Los Angeles, Maitland, Memphis, New York, Oceanside, Orlando, Philadelphia, Phoenix, Princeton, Rockville, San Francisco, San Juan Capistrano, Savannah, Skokie, Springfield, The Bronx, Toms River, and Watertown, United StatesSee the 42 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Source: NCT06605105, who can take part

Where in United States

  • Atlanta Center for Medical ResearchAtlanta, United StatesNo longer taking part
  • Cenexel iResearcvh Atlanta, LLCAtlanta, United StatesNo longer taking part
  • Adams Clinical BostonBoston, United StatesNo longer taking part
  • Neurobehavioral Clinical ResearchCanton, United StatesNo longer taking part
  • Uptown Research InstituteChicago, United StatesNo longer taking part
  • Mountain View Clinical ResearchDenver, United StatesNo longer taking part
  • Adams Clinical DallasDeSoto, United StatesNo longer taking part
  • Cedar Clinical ResearchDraper, United StatesNo longer taking part
  • Institute for Integrative TherapiesEden Prairie, United StatesNo longer taking part
  • Starlight Clinical ResearchEvergreen, United StatesNo longer taking part
  • Behavioral Research Specialists, LLCGlendale, United StatesNo longer taking part
  • Research Centers of AmericaHollywood, United StatesNo longer taking part
  • Zillan Clinical ResearchHouston, United StatesNo longer taking part
  • Clinical Neuroscience SolutionsJacksonville, United StatesNo longer taking part
  • Kadima Neuropsychiatry InstituteLa Jolla, United StatesNo longer taking part
  • K2 Medical ResearchLady Lake, United StatesNo longer taking part
  • Redbird ResearchLas Vegas, United StatesNo longer taking part
  • Segal Trials Center for Psychedelic ResearchLauderhill, United StatesNo longer taking part
  • CalNeuro Research GroupLos Angeles, United StatesNo longer taking part
  • Lipov Medical GroupLos Angeles, United StatesNo longer taking part
  • TRIP Clinic and Psychedelic Science InstituteLos Angeles, United StatesNo longer taking part
  • Accel Research Sites - MaitlandMaitland, United StatesNo longer taking part
  • K2 Medical ResearchMaitland, United StatesNo longer taking part
  • Clinical Neuroscience Solutions, CNS HealthcareMemphis, United StatesNo longer taking part
  • Adams Clinical HarlemNew York, United StatesNo longer taking part
  • Excell Research, Inc.Oceanside, United StatesNo longer taking part
  • Charter ResearchOrlando, United StatesNo longer taking part
  • Clinical Neuroscience Solutions, Inc.Orlando, United StatesNo longer taking part
  • Combined Research Orlando Phase I-IVOrlando, United StatesNo longer taking part
  • Adams Clinical PhiladelphiaPhiladelphia, United StatesNo longer taking part
  • Scottsdale Research InstitutePhoenix, United StatesNo longer taking part
  • Global Medical Institutes Princeton Medical InstitutePrinceton, United StatesNo longer taking part
  • Sunstone Medical, PCRockville, United StatesNo longer taking part
  • Open Mind Collective / UCSF Medical Center - Mount ZionSan Francisco, United StatesNo longer taking part
  • Inland Psychiatric Medical Group Inc (IPMG Research)San Juan Capistrano, United StatesNo longer taking part
  • CenExel iResearchSavannah, United StatesNo longer taking part
  • Psychiatric Medicine AssociatesSkokie, United StatesNo longer taking part
  • Psychiatric Medicine Associates, LLCSkokie, United StatesNo longer taking part
  • Elixia HealthSpringfield, United StatesNo longer taking part
  • Adams Clinical BronxThe Bronx, United StatesNo longer taking part
  • Bio Behavioral HealthToms River, United StatesNo longer taking part
  • Adams ClinicalWatertown, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Cybin IRL Limited
Trial code
NCT06605105EU 2024-516805-22-00
Record updated
25 September 2026
Original 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.Read full original descriptionShow less

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)

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.

Inclusion: 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: Positive urine test for drugs of abuse, or alcohol breath test prior to dosing; newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the APPROACH or EMBRACE trial; Clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions 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; 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; Unwilling to consent to audio and video recording of psychological support and dosing sessions.

ClinicalTrials.gov NCT06605105 · EU CTIS 2024-516805-22-00