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:

• People who are willing and able to give written consent to participate at the screening visit
• People who are between 18 and 65 years old
• People who are able to complete all required study assessments without help or modifications, and can attend all required study visits
• People who have a responsible person or caregiver who can monitor them at home for 24 hours after each treatment visit
• People who have a psychiatrist and/or general practitioner who can provide ongoing mental health care during the study
• People who have a confirmed diagnosis of major depressive disorder (MDD) — either a single episode or recurring — without psychotic features, where the current episode has lasted at least 3 months
• People whose depression is rated as at least moderate severity based on a standard clinical rating scale (a score above 17 on the HAMD-17)

Who may not be able to join:

• People with a current or past diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, psychotic disorder, or delusional disorder
• People with a clinical diagnosis of antisocial personality disorder or paranoid personality disorder
• People with an active diagnosis of borderline personality disorder
• People whose depression is caused by another medical condition or by bipolar I or II disorder
• People who have a first-degree relative (such as a parent or sibling) diagnosed with schizophrenia, a primary psychotic disorder, or bipolar disorder
• People who are currently experiencing any symptoms consistent with psychosis
• People who are currently experiencing any symptoms consistent with hypomania or mania
• People who have had one or more suicide attempts in the past year that required hospitalisation
• People whose personal circumstances or behaviour are considered, by the trial team, to be incompatible with safely participating in the study
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with a lifetime history of a substance use disorder involving hallucinogens
• People with a lifetime history of psychosis caused by substance use
• People who test positive for illicit drugs or drugs of abuse at screening, in the week before treatment, or during the trial (confirm with trial site regarding how results are reviewed)
• People with abnormal and clinically significant findings on a physical examination, vital signs, heart tracing (ECG), or blood tests at screening
• People with a particular heart rhythm abnormality known as QTc prolongation on an ECG
• People with uncontrolled diabetes or diabetes managed with insulin
• People with a history of seizure disorder, except for seizures related to electroconvulsive therapy or childhood febrile seizures
• People with a diagnosis of mild or major neurocognitive disorder (such as dementia or related conditions)
• People with a history of stroke, a heart attack within the past year, uncontrolled high blood pressure, or a clinically significant heart rhythm problem within the past year
• People with any other significant illness affecting the heart, lungs, digestive system, liver, kidneys, or other major organ systems that the investigator considers a health risk or likely to affect study results
• People who have used psilocybin or any other psychedelic substance in the 12 months before screening, or at any point during the current depressive episode
• People with a moderate or severe alcohol or substance use disorder in the past 12 months
• People currently enrolled in another interventional depression study, or who have participated in one within 30 days of screening
• People with abnormal blood test results at screening (these may be repeated by the medical team to see whether they resolve, and eligibility will be reviewed accordingly)

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