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)

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 85 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 468 participants

Study Arms

• CYB003 (EXPERIMENTAL)
  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.

Interventions

• DRUG: CYB003 — CYB003 is a deuterated psilocin analog

Primary Outcomes

• 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)

Eligibility Criteria

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

Trial Locations

• Combined Research Orlando, Phoenix, Arizona, United States
• Open Mind Collective / UCSF Medical Center - Mount Zion, San Francisco, 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
• K2 Medical Research, Lady Lake, Florida, United States
• Segal Trials Center for Psychedelic Research, Lauderhill, Florida, United States
• Clinical Neuroscience Solutions, Inc, Orlando, Florida, United States
• Cenexel iResearcvh Atlanta, LLC, Atlanta, Georgia, United States
• Atlanta Center For Medical Research, Atlanta, Georgia, United States
• ...and 9 more locations

Study Officials

• Clinical Development — STUDY_CHAIR
  Cybin IRL Limited

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