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Enrolling by invitation NCT06605105

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

Phase III Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CYB003.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug CYB003
    CYB003 is a deuterated psilocin analog

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Combined Research Orlando — Phoenix
  • Open Mind Collective / UCSF Medical Center - Mount Zion — San Francisco
  • Inland Psychiatric Medical Group Inc (IPMG Research) — San Juan Capistrano
  • Mountain View Clinical Research — Denver
  • Starlight Clinical Research — Evergreen
  • Research Centers of America — Hollywood
  • K2 Medical Research — Lady Lake
  • Segal Trials Center for Psychedelic Research — Lauderhill
  • … and 20 more centers
Australia · 5 centers
  • Sydney Local Health District — Camperdown
  • Thompson Brain & Mind Healthcare — Maroochydore
  • Neurocentrix Research — Carlton
  • Ramsay Clinic — Melbourne
  • Monash University - Notting Hill — Notting Hill

Identifiers

NCT: NCT06605105 · CYB003-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗