Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This four-arm randomized trial compares conventional therapy, psilocybin therapy, SIRT, and psilocybin-assisted SIRT in adults with trauma-related MDD. Participants will be assessed with the TADE tool and standard measurements like HAM-D, PCL-5, and GAD-7, while researchers track gut-brain axis biomarkers and inflammatory markers. The study integrates a novel TADE assessment and a psychotherapy that blends CBT, DBT, mindfulness, and reframing concepts to see if combining pharmacologic and psychotherapeutic approaches improves outcomes. Eligibility requires adults 18-60 with MDD linked to trauma, stable SSRI therapy, and specific depression, PTSD, and anxiety scores. Exclusions include major cardiovascular, hepatic, renal, or neurological disease and active substance use disorders.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hayatabad Medical Complex Peshawar
  Peshawar, Kpk, Pakistan Recruiting
• Institute of Health Science, Khyber Medical University
  Islamabad, Capital, Pakistan Active not recruiting
• Khyber Medical University
  Peshawar, Kpk, Pakistan Active not recruiting

Study contacts

• Principal investigator: Dr Omer Malik, PhD — Khyber Medical University Peshawar, Pakistan
• Study coordinator: Bushra Riaz, PhD*
• Email: bushrariaz098@gmail.com
• Phone: +92 3338000744

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.