A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety (NCT06820723) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety
United States40 participantsStarted 2025-11
Plain-language summary
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is assigned female or male at birth.
* Participant is aged between 21 to 65 years, inclusive, at Screening.
* Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
* Participant is ≥60 kg.
* Participant has a diagnosis of MDD (as defined in the DSM-5 established through a clinician interview that includes the Mini-International Neuropsychiatric Interview)
* Depression severity moderate to severe based on MADRS score ≥21.
* Anxiety severity moderate to severe based on GAD-7 ≥10.
* Inadequate response to current antidepressant medication in current episode of depression.
* Participant has been on a stable dose (no more than 50% change) of antidepressant medication (SSRI or SNRI) in the last month prior to Screening.
* Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing.
* Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Such participan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of CYB003 in participants with MDD and anxiety
Timeframe: Between Baseline and Time point 24 hours and 21 days post-Investigational Product or placebo
2
Changes in region-to-region connectivity measured by fMRI after one dose of CYB003 in patients with depression and anxiety
Timeframe: Between Baseline and Time point 24 hours and 21 days post-Investigational Product or placebo
3
Changes in event related potentials (ERP) after one dose of CYB003 in participants with MDD and anxiety
Timeframe: Between Baseline and Time point 24 hours and 21 days post-Investigational Product or placebo.
4
Changes in acoustic startle electromyographic (EMG) response after one dose of CYB003 in patients with depression and anxiety
Timeframe: Between Baseline and Time point 24 hours and 21 days post-Investigational Product or placebo.