A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety

Conditions

• Anxiety
• Depression
• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• CYB003 — DRUG
  synthetic, deuterated isotopomer of psilocin
• Placebo — DRUG
  Placebo orange drink solution

Study Details

The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.

Key Dates

First listed

Feb 11, 2025

Start date

Aug 1, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: CYB003
  Participants will receive one dose of CYB003
• Placebo Comparator: Placebo
  Participants will receive one dose of placebo

Primary Outcome Measure

Changes in parameter estimate of regional brain activity measured by fMRI after one dose of CYB003 in participants with MDD and anxiety [ Time Frame: Between Baseline and Time point 24 hours and 21 days post-Investigational Product or placebo ]

Central Contacts

• Anne-Marie Duchemin
  6142935517
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

Related Studies

• Mechanisms of Rumination Change in Adolescent Depression
  Recruiting · Ohio State University · Columbus, Ohio
• Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
  PHASE4 · Recruiting · University of Cincinnati · Cincinnati, Ohio
• A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
  PHASE3 · Recruiting · AbbVie · Anaheim, California
• A Precision Medicine Approach to Target Engagement for Emotion Regulation
  Recruiting · Matthew Southward, PhD · Columbus, Ohio