Magic mushroom compound tested for stubborn bipolar depression
NCT ID NCT06943573
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests whether a single 25 mg dose of psilocybin, given with therapy, can ease depression in people with bipolar II disorder who haven't improved with standard treatments. About 90 adults aged 19-65 will receive either the full dose or a very low placebo dose, and their mood changes will be tracked over 12 weeks. The goal is to see if this approach is safe and effective for treatment-resistant symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. You are male or female aged 19 to 65 years inclusive. 2. You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode. 3. 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 methods of contraception) OR agree to completely abstain from heterosexual intercourse. Females who do not have childbearing potential are required to be postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) OR surgically sterile. 4. 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. 5. Your current medications have been at a stable dose for two weeks prior to the dosing visit. Exclusion Criteria: 1. You have a history of psychotic symptoms. 2. You have a history of seizures. 3. 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). 4. You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression. 5. You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode. 6. 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). 7. You have a history of nonresponse or intolerance to psilocybin. 8. You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms. 9. You have a history of non-response to electroconvulsive therapy. 10. You are pregnant or lactating.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Psychiatry, University of Ottawa, The Ottawa Hospital
NOT_YET_RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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Department of Psychiatry, University of Toronto, University Health Network,
NOT_YET_RECRUITINGToronto, Ontario, M5T 2S8, Canada
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Djavad Mowafaghian Centre for Brain Health
RECRUITINGVancouver, British Columbia, V6T 1Z3, Canada
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Other studies related to the condition(s) this trial covers.
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