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.

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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

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Hayatabad Medical Complex Peshawar

    RECRUITING

    Peshawar, KPK, 25000, Pakistan

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Institute of Health Science, Khyber Medical University

    ACTIVE_NOT_RECRUITING

    Islamabad, Capital, 25000, Pakistan

  • Khyber Medical University

    ACTIVE_NOT_RECRUITING

    Peshawar, KPK, Pakistan

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