Bipolar II Disorder study: Psilocybin vs Therapeutic Support
Official title Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
ClinicalTrials.gov ID: NCT06706232
What this study is testing
What is Psilocybin?
This is an investigational medicine being studied to see if it can help reduce suicidal thoughts in people with Bipolar II Disorder. It is designed to interact with serotonin receptors in the brain to potentially change how you process emotions and thoughts.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if giving up to two sequential 25‑mg doses of psilocybin, with extra therapeutic support, is safe and acceptable for reducing suicidality in bipolar II depression.
- Who it's for
- Adults who have bipolar II disorder, are experiencing depression, and have thoughts of suicide.
- What's involved
- Participants will receive up to two 25‑mg psilocybin doses in a clinical setting, along with therapeutic support and related visits and tests.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 70
You may be able to join if
- 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...
- 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...
- Must meet criteria for depression according to the MADRS cutoff scores: A score of 7-34 indicating mild to moderate depression
You likely can't join if
- 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...
- Have a first or second degree relative with Bipolar I disorder or a psychotic disorder
- Currently experiencing a hypomanic or mixed-symptom episode
See the full eligibility 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...
- 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...
- 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...
- Willingness to taper down mood stabilizers and other relevant medications (including but not limited to: antidepressants, antipsychotics, lithium, benzodiazepines, Monoamine oxidase inhibitors (MAOIs), Selective...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.