Phase 1 Bipolar Disorder 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:

• Adults between 18 and 65 years old.
• People who are considered able to make their own informed decisions about taking part in research.
• People who are willing to sign and date a consent form and follow all study procedures.
• People who can read and communicate in English well enough to understand the consent form and study questionnaires, as assessed by study staff.
• People who have a diagnosis of Bipolar II Disorder and are currently going through a moderate to severe depressive episode (without psychosis), confirmed by a mood specialist and a structured clinical interview.
• People whose current depressive episode has not responded well enough to at least two appropriate treatments for bipolar depression, as assessed using standard guidelines.
• People who are able to swallow oral (by mouth) medication.
• People who are currently taking a medication called lamotrigine, or who are planning to start it outside of the trial and continue it without changes throughout the entire study period, including a one-month follow-up.
• People who are capable of becoming pregnant and have been using highly effective contraception for at least three months before screening, and who agree to continue using it during the study.
• People who are capable of fathering a child and agree to use condoms or other effective contraception with their partner throughout the study.
• People who are willing to taper off certain current medications for at least one month before the study begins, and whose own doctor confirms it is safe to do so.
• People who agree to follow the lifestyle guidelines set out by the study for its full duration.

Who may not be able to join:

• People who are pregnant (as confirmed by a urine test at screening), planning to become pregnant during the study, or currently breastfeeding.
• People who have taken part in another clinical trial or received an experimental treatment within the 30 days before screening.
• People who are currently experiencing symptoms of mania, hypomania, or mixed mood features, as measured by a standard rating scale.
• People who have had a manic or hypomanic episode in the past six months.
• People who have been diagnosed with a substance use disorder (not including tobacco use) in the past 12 months.
• People who are experiencing active suicidal thoughts at a significant level, as assessed by a clinical interview and standard scale, or who have made a suicide attempt in the past three months.
• People who have ever been diagnosed with schizophrenia or a related condition, a psychotic disorder, Bipolar I Disorder, paranoid personality disorder, borderline personality disorder, or a significant neurocognitive disorder.
• People who have a medical reason that makes MRI brain scanning unsafe for them, as determined by an MRI questionnaire.
• People who have a history of seizures.
• People who are currently taking anti-seizure medications (other than lamotrigine) or sedative medications called benzodiazepines (a low dose of lorazepam may be acceptable — confirm with trial site).
• People who have a history of, or suspected, a serious skin reaction called Stevens-Johnson Syndrome.
• People who have a close biological relative (parent, sibling, or child) diagnosed with schizophrenia or a related condition, a psychotic disorder (unless caused by a substance or medical condition), or Bipolar I Disorder.
• People who have a medical reason that makes taking psilocybin unsafe, including a known drug allergy, recent stroke, uncontrolled high blood pressure, very low or unstable blood pressure, recent heart attack, heart rhythm problems, severe coronary artery disease, or moderate to severe kidney or liver problems.
• People who have certain heart-related electrical abnormalities (prolonged QTc or Torsade de Pointes) detected on a heart tracing (ECG), or a history of related heart conditions.
• People who are allergic to lamotrigine or psilocybin, or who have been unable to tolerate lamotrigine.
• People who are unwilling or unable to continue taking lamotrigine as prescribed throughout the entire study, including up to the four-week post-dose visit.
• People who have used classic psychedelic substances (such as psilocybin, LSD, DMT, or mescaline) in the six months before signing the consent form.
• People who have used steroid medications (intravenous or oral) within one week before receiving the study drug.
• People who have used certain supplements — SAM-e, 5-HTP, L-tryptophan, or St. John's Wort — within one week before receiving the study drug.
• People with any other significant physical health condition that, in the opinion of the study investigators, could interfere with the study results or pose a health risk to the participant.

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