Clinical trial for Bipolar II Depression
Official title Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
ClinicalTrials.gov ID: NCT06943573
What this study is testing
What is psilocybin (25 mg)?
investigational single-dose psilocybin‑assisted therapy being studied as a potential treatment for bipolar II depression psilocybin is designed to act as a serotonin (5‑HT2A) receptor agonist that changes brain signaling
Also referred to as psilocybin.
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 wants to see if psilocybin‑assisted therapy is safe and works better than a very low dose placebo in people whose bipolar II depression did not respond to usual treatments.
- Who it's for
- Adults with bipolar II depression who have tried at least two standard medications without enough improvement.
- What's involved
- Participants receive one dose of psilocybin (or a tiny placebo dose) plus five therapy sessions with trained therapists, and attend regular study visits for monitoring and tests.
- Time commitment
- The trial lasts about 12 weeks of treatment plus up to 30 days of screening, with a total of 11 visits over roughly 16 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65
You may be able to join if
- You are male or female aged 19 to 65 years inclusive.
- You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode.
- You are willing, for the entire duration of the study, to practice highly effective methods of contraception (e.g., contraceptive pills, intrauterine...
- You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic...
- Your current medications have been at a stable dose for two weeks prior to the dosing visit.
You likely can't join if
- You have a history of psychotic symptoms.
- You have a history of seizures.
- You have a first-degree relative, such as your parent, sibling, or child, with a diagnosis of a primary psychotic disorder (e.g., schizoaffective...
- You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression.
- You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode.
- You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy...
See the full eligibility criteria
- You are male or female aged 19 to 65 years inclusive.
- You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode.
- You are willing, for the entire duration of the study, to practice highly effective methods of contraception (e.g., contraceptive pills, intrauterine device or system, vasectomy and tubal ligation, or double-barrier...
- You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations.
- Your current medications have been at a stable dose for two weeks prior to the dosing visit.
- You have a history of psychotic symptoms.
- You have a history of seizures.
- You have a first-degree relative, such as your parent, sibling, or child, with a diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder, schizophrenia).
- You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression.
- You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode.
- You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- You have a history of nonresponse or intolerance to psilocybin.
- You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms.
- You have a history of non-response to electroconvulsive therapy.
- You are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
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 - 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, 19 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.