Psilocin for the Treatment of Major Depressive Disorder

Clinical Trial Title An Efficacy and Safety Study Comparing 2 Active Doses of CYB003 and Placebo for the Treatment of Major Depressive Disorder

National Clinical Trial Number: NCT06793397

Clinical Trial Protocol Description:

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with major depressive disorder (MDD).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Are 18 to 85 years of age.
Have a diagnosis of moderate to severe MDD.
Have been on a stable dose of antidepressant medication at an adequate dose for at least 4 weeks.
Have a body mass index (BMI) of 40 kg/m2 or less.
Are able to refrain from smoking during the dosing session.
Female participants of childbearing potential must agree to use a highly effective method of birth control and have a negative pregnancy test.

You will be excluded from the study if any of the following criteria apply to you:

Are currently or have previously been diagnosed schizophrenia spectrum or other psychotic disorders.
Have a family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
Have a significant suicide risk within 12 months of screening.
Are currently or have previously been diagnosed with treatment-resistant MDD.
Have had electroconvulsive treatment (ECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), or vagal nerve stimulation (VNS) for any episode of MDD in the last 6 months.
Are currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, mirtazapine, trazodone, moclobemide, buspirone, an antipsychotic or a mood stabilizer.
Have a clinically relevant history of abnormal physical health that may interfere with the study.
Have hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.
Have a current diagnosis of uncontrolled hypertension or arrhythmia.
Have clinically relevant abnormal results for heart rate.
Have current or history of organic brain disorders.
Have a history of serotonin syndrome.
Are unwilling to consent to audio and video recording of psychological support and dosing sessions.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.