Phase III Long-term Extension Trial to Assess Safety and... | NCT06605105

Status Module

Name	Class
Worldwide Clinical Trials	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: CYB003

Name	Type	Description	Arm Group Labels	Other Names
CYB003	Drug	CYB003 is a deuterated psilocin analog	CYB003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	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. The scale consists of ten items rated on a scale from 0 to 6, resulting in a total score ranging from 0 (normal / symptom absent) to 60 (severe depression).	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 Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Combined Research Orlando		Phoenix	Arizona	85022	United States
Open Mind Collective / UCSF Medical Center - Mount Zion

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression