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Psychedelic-Assisted therapy targets Gut-Brain link in trauma depression

NCT ID NCT07703722

Disease control Sponsor: Khyber Medical University Peshawar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18-60 years. * Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria. * Trauma-related depression with clinically significant trauma symptoms. * Hamilton Depression Rating Scale (HAM-D) score \>16. * PTSD Checklist for DSM-5 (PCL-5) score \>33. * Generalized Anxiety Disorder-7 (GAD-7) score \>10. * Receiving a stable single SSRI antidepressant regimen for at least 6 weeks before enrollment with adequate treatment adherence. * Able and willing to provide written informed consent. * Willing to comply with all study procedures and follow-up visits. * Women of childbearing potential must agree to use effective contraception throughout the study. Exclusion Criteria: * Significant cardiovascular disease. * Clinically significant hepatic or renal impairment. * Significant neurological disorders. * Current or past psychotic disorder or bipolar disorder. * Current substance or alcohol use disorder, including ketamine or psychedelic drug use. * Use of more than one antidepressant medication. * Pregnancy, planned pregnancy, or breastfeeding. * Known hypersensitivity or contraindication to psilocybin. * Participation in another interventional clinical trial within the previous 30 days. * Inability or unwillingness to provide informed consent. * Any medical or psychiatric condition that, in the investigator's opinion, would interfere with safe participation or study assessments.

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Conditions

The condition(s) this trial relates to.

injury major depressive disorder post-traumatic stress disorder

As listed by the trial registrant

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

Major depressive disorder Post-traumatic stress disorder (PTSD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hayatabad Medical Complex Peshawar

    RECRUITING

    Peshawar, KPK, 25000, Pakistan

  • Institute of Health Science, Khyber Medical University

    ACTIVE_NOT_RECRUITING

    Islamabad, Capital, 25000, Pakistan

  • Khyber Medical University

    ACTIVE_NOT_RECRUITING

    Peshawar, KPK, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.