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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Cybin IRL Limited
Study ID
NCT06605105
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • CYB003 — DRUG
    CYB003 is a deuterated psilocin analog

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Mar 2026
Primary completion
Mar 15, 2028
Completion
Mar 15, 2028

Study Design

Enrollment
468 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CYB003
    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.

Primary Outcome Measure

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 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Combined Research OrlandoPhoenixArizona85022-
Open Mind Collective / UCSF Medical Center - Mount ZionSan FranciscoCalifornia94114-
Mountain View Clinical ResearchDenverColorado80209-
Starlight Clinical ResearchEvergreenColorado80439-
Research Centers of AmericaHollywoodFlorida33024-
K2 Medical ResearchLady LakeFlorida32159-
Segal Trials Center for Psychedelic ResearchLauderhillFlorida33319-
Clinical Neuroscience Solutions, IncOrlandoFlorida32801-
Atlanta Center For Medical ResearchAtlantaGeorgia30331-
Cenexel iResearcvh Atlanta, LLCAtlantaGeorgia30030-
CenExel iResearchSavannahGeorgia31405-
Uptown Research InstituteChicagoIllinois60640-
Psychiatric Medicine Associates, LLCSkokieIllinois60076-
Sunstone Medical, PCRockvilleMaryland20850-
Adams Clinical BostonBostonMassachusetts02116-
Adams ClinicalWatertownMassachusetts02472-
Neurobehavioral Clinical ResearchCantonOhio44720-
InSite Clinical Research, LLCDeSotoTexas75115-
Cedar Clinical ResearchDraperUtah84020-

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Combined Research Orlando· Phoenix, AZOpen Mind Collective / UCSF Medical Center - Mount Zion· San Francisco, CAMountain View Clinical Research· Denver, COStarlight Clinical Research· Evergreen, COResearch Centers of America· Hollywood, FLK2 Medical Research· Lady Lake, FL

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