What is CYB003 studying for depression and anxiety?

CYB003 is being studied to understand its effects on brain activity and symptoms in people with major depressive disorder and anxiety who have not fully responded to antidepressants. The trial evaluates how a single dose affects brain function and emotional symptoms using brain imaging and clinical assessments. The study is sponsored by Ohio State University to explore new treatment approaches.

Who may be eligible for this depression and anxiety clinical trial?

Adults aged 21 to 65 with moderate to severe major depressive disorder and anxiety symptoms may be eligible. Participants must be on a stable dose of antidepressants and meet specific health criteria. Both males and females assigned at birth can join. Please review eligibility criteria for more details.

Is there any cost to participate in this depression and anxiety clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 21Years - 65Years

All Genders

ID06820723

Study of One Oral Dose of CYB003 to Explore Effects on Brain Activity in Adults With Major Depressive Disorder and Moderate to Severe Anxiety

Led by Ohio State University · Updated on 2026-07-23

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to understand how psychedelics might help treat symptoms of depression and anxiety in people diagnosed with major depressive disorder MDD experiencing moderate to severe symptoms. The study focuses on CYB003, a synthetic form of psilocin the active part of psilocybin, to explore its effects on brain activity and connectivity, as well as symptom changes. It is a randomized, double-blind, placebo-controlled Phase 2 trial involving adults aged 21 to 65 with ongoing depressive and anxiety symptoms despite current antidepressant treatments. Participants will be randomly assigned to receive one oral dose of either 16 mg of CYB003 or a placebo orange drink. Psychological support is provided before, during, and after the dosing session. Assessments occur at baseline, 2 days, and 21 days after dosing and include brain scans EEGEMG and MRI, clinical rating scales for depression and anxiety, cognitive tests, questionnaires about psychedelic effects, and blood tests for biomarkers. During the study, participants will complete interviews and self-report questionnaires to track symptom changes. Brain activity and connectivity are measured using functional MRI and EEG. Safety and symptom effects are monitored through clinical scales such as MADRS and HAM-A. The study measures changes at 24 hours and 21 days after dosing to understand short- and longer-term effects. The trial is expected to continue until November 2028, with participant involvement spanning the dosing and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant is assigned female or male at birth.
Age between 21 and 65 years at screening.
Body mass index (BMI) between 18 and 30 kg/m2.
Weight of at least 60 kg.
Diagnosed with major depressive disorder (MDD) by a clinician.
Moderate to severe depression with MADRS score of 21 or higher.
Moderate to severe anxiety with GAD-7 score of 10 or higher.
Inadequate response to current antidepressant in current depression episode.
Stable antidepressant dose (no more than 50% change) in last month.
Use of effective contraception if of childbearing potential and negative pregnancy test.
Postmenopausal or permanently sterile if not of childbearing potential.
Willing to give written informed consent and comply with study requirements.

You will not qualify if you...

Reduction in MADRS score of 25% or more between screening and baseline.
Failure to respond to more than 2 antidepressants in current episode.
Current or past diagnosis of schizophrenia spectrum, bipolar disorder, personality disorder.
Clinically significant risk of suicidality or high suicide ideation score.
Substance use disorder within 12 months or excessive alcohol use.
Use of certain antidepressants, antipsychotics, or mood stabilizers.
Use of psychedelics more than 10 times in 10 years or within 6 months.
Use of psychotropic medicines or supplements interacting with psilocybin within 28 days.
Family history of schizophrenia, schizoaffective disorder, or bipolar type 1.
Significant abnormal physical health or medical conditions interfering with study.
Presence of organic brain disorders or seizure-related conditions.
Diagnosis of hypertension, arrhythmia, or abnormal heart rate or blood pressure.
Abnormal ECG findings or QT interval above 450 msec.
Hypothyroidism or abnormal thyroid function.
Abnormal laboratory results or physical findings judged clinically relevant.
Other conditions posing unacceptable risk or interfering with study.
Not fluent in English.
Positive drug or alcohol tests at screening or Day 1.
Excessive caffeine or methylxanthine consumption.
Participation in other clinical studies with medication within 3 months.
Known sensitivity to psilocin or excipients.
Use of monoamine oxidase inhibitors or certain supplements within 28 days.
Strenuous exercise within 48 hours before visits.
Not willing to abstain from sperm donation or use contraception as required.
Pregnancy, breastfeeding, or planning to conceive if of childbearing potential.

Research Team

Anne-Marie Duchemin

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Study of One Oral Dose of CYB003 to Explore Effects on Brain Activity in Adults With Major Depressive Disorder and Moderate to Severe Anxiety

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria