"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• CYB003 — DRUG
  CYB003 is a Deuterated Psilocin Analog.
• Psychological Support — BEHAVIORAL
  Manualized psychological support performed by facilitators
• Placebo — DRUG
  Placebo

Study Details

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

Key Dates

Start date

Dec 17, 2024

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm A: CYB003 in 2 of 2 Dosing Sessions
  Arm A participants will receive 16 mg of CYB003 in 2 of 2 medicine sessions, approximately three weeks apart. All Arm A participants will continue on their current antidepressants and receive psychological support throughout the study.
• Placebo Comparator: Placebo Comparator Arm B: Placebo in 2 of 2 Dosing Sessions
  Arm B participants will receive placebo in 2 of 2 Dosing Sessions, approximately three weeks apart. All Arm B participants will continue on their current antidepressants and receive psychological support throughout the study. Non-responders will be eligible to receive CYB003 in a subsequent extension trial.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Screening Day-45, Baseline Day-1, Day 2, Day 10, Day 21, Day 23, Day 31, and Day 42 (End of Treatment) ]

Central Contacts

• Clinical Development
  877-361-4003
  [email protected]

Locations (46)

Find similar trials in Phoenix, AZ

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