Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder
Recruiting
Phase 3
Interventional Study
Major Depressive Disorder
Post-Traumatic Stress Disorder (PTSD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Khyber Medical University Peshawar · Other
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About This Trial
Trauma-related Major Depressive Disorder (MDD) is frequently associated with poor response to conventional antidepressants, persistent psychological distress, and alterations in gut-brain axis function. Existing assessment tools primarily diagnose depression or PTSD but provide limited guidance for integrated clinical management. This study aims to develop and validate the Trauma Anxiety Depressio…
Trial Locations
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Eligibility Criteria
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.
*…
Contacts