Psychedelic-Assisted therapy targets Gut-Brain link in trauma depression
NCT ID NCT07703722
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This Phase 3 trial investigates whether a psychedelic drug, psilocybin, combined with a specialized trauma-focused therapy (SIRT), can improve depression and anxiety in people with trauma-related major depressive disorder. The study also looks at changes in gut-brain axis biomarkers, such as inflammatory markers and gut permeability proteins. Participants will be randomly assigned to receive either standard care, psilocybin alone, SIRT alone, or psilocybin plus SIRT, with outcomes measured over 12 weeks.
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, combined with a structured psychotherapy called Structured Integrated Reframing Therapy (SIRT)
- What this could lead to
- If successful, this could point toward a more effective treatment for people with trauma-related depression that hasn't responded well to standard antidepressants.
- What could go wrong
- This is a relatively small early-phase trial, and the effects of psilocybin can vary widely. The therapy is intensive and may not be suitable for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Hayatabad Medical Complex Peshawar
RECRUITINGPeshawar, KPK, 25000, Pakistan
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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Institute of Health Science, Khyber Medical University
ACTIVE_NOT_RECRUITINGIslamabad, Capital, 25000, Pakistan
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Khyber Medical University
ACTIVE_NOT_RECRUITINGPeshawar, KPK, Pakistan
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