RECRUITING

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

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Conditions

Bipolar II DisorderDepression, BipolarSuicidalityBipolar II DepressionPsilocybin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06706232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have completed written informed consent
  2. * Must be at 25 years of age or older at screening (but below age of 70)
  3. * 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)
  4. * 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
  5. * Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression
  6. * 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)
  7. * 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
  8. * Willingness to stop allowed medication at least 24 h prior to administration of psilocybin as advised by study physician (e.g., benzodiazepines)
  9. * Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
  1. * Participants who do not read/speak English
  2. * Active suicidal ideation with at least some intent and/or plan (i.e., a current score of 4 or 5 on the C-SSRS)
  3. * History of medically significant suicide attempt in the last 6 months
  4. * 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
  5. * Have a first or second degree relative with Bipolar I disorder or a psychotic disorder
  6. * Currently experiencing a hypomanic or mixed-symptom episode
  7. * Have a psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
  8. * 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

Contacts and Locations

Study Contact

Thomas Meyer, PhD
CONTACT
713-486-2643
thomas.d.meyer@uth.tmc.edu
Lauren Vale, MA
CONTACT
713-486-2643
lauren.n.vale@uth.tmc.edu

Principal Investigator

Thomas Meyer, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77006
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Thomas Meyer, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-03
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Bipolar II Depression
  • Psilocybin

Additional Relevant MeSH Terms

  • Bipolar II Disorder
  • Depression, Bipolar
  • Suicidality