Phase 3 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 able to understand and sign a consent form, showing they understand what the study involves.
• People who are between 18 and 55 years old at the time of screening.
• People who have been diagnosed with at least moderate Major Depressive Disorder (MDD), either as a single episode lasting between 3 months and 3 years, or as a recurring condition.
• People whose depression scores on a standard rating scale are 18 or above, both at the screening visit and the baseline visit.
• People whose current episode of depression has not responded adequately to between 1 and 4 antidepressant treatments (including combination treatments where relevant).
• People who score below 7 on a screening tool used to assess for borderline personality disorder.
• People who are able to taper off all psychiatric medications under the supervision of a study psychiatrist, completing this at least 2 weeks before the baseline scan.
• People who score above 40 on a standard adult reading test.
• People who are right-handed, as confirmed by a standard handedness assessment.
• People who are able to complete all required study assessments without assistance and attend all required study visits.
• People who have an ongoing, established relationship with a mental health care provider.

Who may not be able to join:

• People with a current, past, or family history of schizophrenia, bipolar disorder, psychotic disorders (unless caused by substances or a medical condition), delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or other serious psychiatric conditions.
• People who have metal implants, claustrophobia, or other factors that make having an MRI scan unsafe or unsuitable.
• People who have previously received electroconvulsive therapy (ECT) or ketamine for their current episode of depression.
• People currently receiving cognitive behavioural therapy (CBT) that would not remain stable throughout the study, or where CBT has been started within 21 days before the baseline visit.
• People with alcohol or substance misuse problems in the past year, as assessed at screening.
• People who have experienced significant suicidal thoughts or behaviours in the past year, or where a clinical interview identifies significant suicide risk.
• People identified as having significant risk of harm to others, based on a clinical interview.
• People whose depression appears to be directly caused by another serious medical condition.
• People who are currently taking benzodiazepines (a type of sedative medication) every day.
• People whose personal circumstances or behaviour are judged to make safe participation unsuitable, or who have used psilocybin or other psychedelic substances within one year before screening.
• People who are pregnant, breastfeeding, or planning to become pregnant; people who are sexually active must agree to use a highly effective form of contraception throughout the study, and women of childbearing potential must have a negative pregnancy test at screening and the day before receiving psilocybin.
• People with certain heart or blood vessel conditions, including a stroke or heart attack in the past year, high blood pressure above 140/90 mmHg, certain heart rhythm abnormalities within the past year, current blood-thinning medication use, or aneurysm.
• People with uncontrolled insulin-dependent diabetes.
• People with a seizure disorder (epilepsy).
• People who test positive for illicit or non-prescribed drugs on a urine drug screen at screening or the day before receiving psilocybin (the trial site will review any positive result to determine eligibility).
• People with a history of brain surgery, brain infections (such as encephalitis or meningitis), degenerative brain conditions (such as Alzheimer's or Parkinson's disease), epilepsy, intellectual disability, significant head injury in the past 2 years, or any other condition affecting the brain or nervous system that the screening clinician considers relevant.
• People with any current or past physical health condition that, in the investigator's opinion, could affect their safety or the interpretation of study results.
• People who are currently enrolled in, or who have participated in, another investigational drug or device study within the past 6 months.
• People who are currently enrolled in, or who have participated in, another interventional depression study within the past 6 months.
• People who are not native English speakers.

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