NCT07703722 Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder
| NCT ID | NCT07703722 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Khyber Medical University Peshawar |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-10-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2026-04-01 with a primary completion date of 2027-10-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Depression Emotion (TADE) management tool while simultaneously evaluating the effectiveness of psilocybin-assisted Structured Integrated Reframing Therapy (SIRT) in improving clinical and biological outcomes. This prospective, four-arm randomized controlled trial will compare conventional therapy, psilocybin therapy, SIRT, and psilocybin-assisted SIRT. Participants will undergo assessment using the newly developed TADE tool together with established psychometric scales including HAM-D, PCL-5, and GAD-7. Biological outcomes will include serum gut-brain axis and inflammatory biomarkers, including Short-Chain Fatty Acids (SCFAs), Interleukin-6 (IL-6), Interleukin-10 (IL-10), Zonulin, Occludin, and Glial Cell Line-Derived Neurotrophic Factor (GDNF). Assessments will be performed at baseline, during treatment, and at 12-week follow-up. The study aims to determine whether combining psilocybin with SIRT provides superior clinical improvement and favorable biological changes compared with either intervention alone while establishing the validity and clinical utility of the TADE management tool.
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. * 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.
Contact & Investigator
Dr Omer Malik, PhD
PRINCIPAL INVESTIGATOR
Khyber Medical University Peshawar, Pakistan
Frequently Asked Questions
Who can join the NCT07703722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07703722 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT07703722 currently recruiting?
Yes, NCT07703722 is actively recruiting participants. Contact the research team at bushrariaz098@gmail.com for enrollment information.
Where is the NCT07703722 trial being conducted?
This trial is being conducted at Islamabad, Pakistan, Peshawar, Pakistan, Peshawar, Pakistan.
Who is sponsoring the NCT07703722 clinical trial?
NCT07703722 is sponsored by Khyber Medical University Peshawar. The principal investigator is Dr Omer Malik, PhD at Khyber Medical University Peshawar, Pakistan. The trial plans to enroll 60 participants.