The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression.
Must have completed written informed consent
Must be at 25 years of age or older at screening (but below age of 70)
Confirmed Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of BD-II using clinical records and Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders (DIAMOND)
Must meet criteria for suicidality according to the INQ cutoff scores: A score of at least 12 on the Perceived Burden (PB) subscale and at least a score of 36 on the Thwarted Belongingness (TB) subscale indicating substantial risk for passive suicidal ideation
Participants who do not read/speak English
Active suicidal ideation with at least some intent and/or plan (i.e., a current score of 4 or 5 on the C-SSRS)
History of medically significant suicide attempt in the last 6 months
Current or past history of Bipolar I disorder, psychotic symptoms or psychotic disorder, (including but not limited to schizophrenia, delusional disorder, schizoaffective disorder) clinically relevant personality disorder (such as borderline, antisocial, narcissistic or paranoid personality disorder), or any serious psychiatric comorbidity considered negatively impacting participation or safety (e.g., PTSD or severe substance use or alcohol disorder) assessed by medical history and/or a structured clinical interview
Single group
Psilocybin
DrugTwo sequential administrations of 25 mg psilocybin, 4 weeks apart.
Therapeutic Support
BehavioralFive preparatory in-person psychotherapy sessions will be offered before the first administration session during weeks 1, 2, 3, 4, and 5. The optional second administration session will be preceded by a shorter 60 min preparatory session the day before. Each administration session will be followed by 3 integration sessions and will adopt a Mindfulness-based CBT approach (M-CBT), in which a therapist will help the participant to process their experience and how to translate this into actual changes in everyday life. If participants prefer more psychological support after the second administration session, they will be offered additional, optional therapy sessions for the duration of the trial regardless if they opted for a second administration session or not.
Feasibility as Assessed by Number of Participants who Complete the Trial (Overall Retention)
This is assessed by number of participants who complete the trial, that is, the number of participants who complete the first dose and follow-up visits up to 3 weeks after the first dose.
Feasibility as Assessed by Number of Therapy Sessions Attended
Feasibility as Assessed by Number of Assessments Completed
Acceptability of Two Dosing Sessions as Assessed by Number of Participants who Choose to Participate in a Second Administration Session
Score on the Montgomery-Åsberg Depression Rating Scale (MADRS)
The total score on the MADRS ranges from 0 to 60, with a higher score indicating a greater depression.
Score on the Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Total score on the QIDS-SR16 ranges from 0 to 27, where higher scores indicate a higher occurence of depressive symptoms.
Score on the Young Mania Rating Scale (YMRS)
The total score on the YMRS ranges from 0 to 60, with higher scores indicating greater severity of mania.
Psychiatric Symptoms as Assessed by Score on the Brief Psychiatric Rating Scale (positive symptom subscale) (BPRS+)
The total score on the BPRS+ ranges from 4 to 28, with higher scores indicating a higher severity of psychopathology.
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The University of Texas Health Science Center, Houston
Lead sponsor
Anne and Don Fizer Foundation
Collaborator
