Can a single psychedelic dose rewire the depressed brain?

NCT ID NCT06506019

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This pilot study is testing whether one 25 mg dose of psilocybin, given alongside psychotherapy, can ease depression in people with bipolar II disorder who haven't responded to at least two prior treatments. Using brain scans (fMRI), researchers will look at how the drug affects the amygdala, a brain region involved in emotion, and whether changes there relate to mood improvements. The study involves 30 adults and will also check if the approach is practical and acceptable to participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
psilocybin (a psychedelic compound) given as a single 25 mg oral dose, combined with psychotherapy sessions
What this could lead to
If successful, this could point toward a new treatment option for people with bipolar depression who haven't improved with standard therapies.
What could go wrong
This is a small, early-stage pilot study, so results may not apply broadly. Psilocybin can cause intense psychological effects and requires careful monitoring.

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder Depression Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Toronto Western Hospital - University Health Network

    Toronto, Ontario, M5T 2S8, Canada

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