Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression

The University of Texas System (UT)

Status and phase

Enrolling

Phase 2

Conditions

Suicidality

Depression, Bipolar

Bipolar II Disorder

Treatments

Drug: Psilocybin

Behavioral: Therapeutic Support

Study type

Interventional

Funder types

Other

Identifiers

NCT06706232

HSC-MS-23-0905

Details and patient eligibility

About

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.

Full description

This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatment for Bipolar II (BD II) depression, specifically, individuals experiencing suicidal ideation (without having an active plan or intention to act). The design is a non-randomized clinical trial, where patients will receive up to 2 doses of 25mg psilocybin in the context of psychological support informed by mindfulness-based CBT and typical elements of psychedelic treatments (e.g., preparation, intention setting, integration). The investigators will measure suicidality, depression, and acute experiences using validated questionnaires at multiple time points in the study. If this study shows psilocybin to be a feasible, acceptable, and safe treatment option, this would have huge implications for improving outcomes because highly effective treatment for suicidality in patients with Bipolar Disorder is still lacking.

Enrollment

10 estimated patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 17 on the Perceived Burden (PB) subscale and at least a score of 22 on the Thwarted Belongingness (TB) subscale indicating substantial risk for passive suicidal ideation
Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression
Must pass medical examination (physical exam, personal/family medical history, including consultation with current medical provider, ECG, about 4 tablespoons blood draw, psychiatric/psychological assessments, urine drug test)
Willingness to taper down mood stabilizers and other relevant medications (including but not limited to: antidepressants, antipsychotics, lithium, benzodiazepines, Monoamine oxidase inhibitors (MAOIs), Selective serotonin reuptake inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), A serotonin-norepinephrine-dopamine reuptake inhibitors (SNDRIs), Tricyclic antidepressants (TCAs), stimulants, cannabis, and other medications, supplements or therapeutics that affect serotonergic function) for the duration of the study before and during administration days (starting 5 weeks before administration), and be off medication for at least 2 weeks prior to administration
Willingness to stop allowed medication at least 24 h prior to administration of psilocybin as advised by study physician (e.g., benzodiazepines)
Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits

Exclusion criteria

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
Have a first or second degree relative with Bipolar I disorder or a psychotic disorder
Currently experiencing a hypomanic or mixed-symptom episode
Have a psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Any indication of a Personality Disorder (PD) such as but not limited to Borderline, Narcissistic, Antisocial, Paranoid, or Schizotypal PD based on Structured Clinical Interview for DSM-5 for PD and/or clinical judgment