Phase 2 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 65 years old
• You are able to make your own informed decisions and agree to take part in the study
• You are able to read and communicate in English well enough to understand the consent forms and questionnaires
• You have been diagnosed with major depressive disorder (MDD) without psychosis, based on a formal clinical interview
• Your depression has not improved after trying two or more antidepressant medications at the right dose and for long enough, and your current depression symptoms score above a certain level on a standard scale
• You are able to swallow oral (pill-form) medication
• If you are capable of becoming pregnant, you have been using highly effective birth control for at least 3 months before screening and agree to continue during the study
• You are willing and medically able (confirmed by your doctor) to gradually stop taking current antidepressant or antipsychotic medications for at least 2 weeks before the study begins
• You agree to follow the lifestyle guidelines required throughout the study

Who may not be able to join:

• You are currently pregnant, planning to become pregnant during the study, or are breastfeeding
• You have taken part in another clinical trial or received an experimental treatment within the past 30 days
• You have started a new course of psychotherapy (talk therapy) within the past 12 weeks
• You have been diagnosed with a substance use disorder (not including tobacco) within the past 6 months
• You are currently experiencing active thoughts of suicide with a specific intent and plan
• You have ever been diagnosed with certain serious mental health conditions, including schizophrenia, bipolar disorder (type I or II), obsessive-compulsive disorder, certain personality disorders, or significant memory/thinking disorders
• A close blood relative (parent, sibling, or child) has been diagnosed with schizophrenia, a psychotic disorder, or bipolar I disorder
• You have a medical reason why you cannot safely take psilocybin, such as a drug allergy to it, a recent stroke, uncontrolled high blood pressure, unstable blood pressure, a recent heart attack, irregular heart rhythm, severe heart disease, or significant kidney or liver problems
• You have a specific heart rhythm problem called prolonged QTc or Torsade de Pointes, or a history of related heart conditions, as seen on a heart tracing (ECG)
• You have a known allergy or medical reason why you cannot take risperidone (a medication used in the study)
• You have a history of traumatic brain injury or any neurological or brain-related condition
• You are unable or unwilling to have PET or MRI scans — for example, due to claustrophobia or having a pacemaker
• You have a blood clotting disorder or are currently taking blood-thinning medication
• You have a disability that would prevent you from completing study requirements — for example, not being able to lie still in a scanner for 1–2 hours
• You have already reached a safe yearly or lifetime limit for radiation exposure (confirm with trial site)
• You have another significant physical health condition that, in the opinion of the study doctor, could affect the study results or put your health at risk

Important: Always verify eligibility with the trial site directly before applying.