Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from the 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 have signed a written consent form agreeing to take part in the study.
• People who are aged 25 to 69 years old at the time of screening.
• People who have a confirmed diagnosis of Bipolar II Disorder (a specific type of bipolar disorder), verified through clinical records and a structured diagnostic interview.
• People whose scores on a specific questionnaire (the INQ) reach certain thresholds linked to passive suicidal thoughts — specifically, a score of at least 12 on the Perceived Burden section and at least 36 on the Thwarted Belongingness section.
• People whose scores on a depression assessment (the MADRS) fall between 7 and 34, indicating mild to moderate depression.
• People who pass a full medical check-up, which includes a physical exam, personal and family medical history review, a consultation with their current doctor, a heart tracing (ECG), a blood draw of about four tablespoons, psychological assessments, and a urine drug test.
• People who are willing to gradually reduce and then stop certain medications — including mood stabilisers, antidepressants, antipsychotics, lithium, and others that affect brain chemistry — starting five weeks before the treatment days, and to be off these medications for at least two weeks before administration.
• People who are willing to stop certain allowed medications (such as benzodiazepines) at least 24 hours before the psilocybin session, as directed by the study doctor.
• People who are able to complete all required study assessments without assistance and attend all required study visits.

Who may not be able to join:

• People who do not read or speak English.
• People who are currently experiencing active suicidal thoughts with some level of intent or a plan (indicated by a score of 4 or 5 on a standard suicide rating scale).
• People who have had a medically serious suicide attempt within the past six months.
• People with a current or past diagnosis of Bipolar I Disorder, psychosis, schizophrenia, delusional disorder, schizoaffective disorder, or certain personality disorders (such as borderline, antisocial, narcissistic, or paranoid), or any serious psychiatric condition that could affect safety or participation — including severe PTSD or severe substance or alcohol use disorder.
• People who have a parent, sibling, or grandparent with Bipolar I Disorder or a psychotic disorder.
• People who are currently in a hypomanic or mixed-mood episode.
• People with any psychiatric or other condition that the study team determines would make it unsafe or unsuitable for them to participate in psilocybin sessions.
• People who show any signs of a personality disorder — including but not limited to Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal — based on a structured clinical interview or clinical judgement.

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