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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06820723
Phase
PHASE2
Status
Recruiting
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Conditions

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

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Department of PsychiatryColumbusOhio43210
Anne-Marie Duchemin
[email protected]
6142935517

Find similar trials in Columbus, OH

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By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
The Ohio State University Department of Psychiatry· Columbus, OH

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