[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645471":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":46,"centralContacts":57,"locations":67,"responsibleParty":103,"collaborators":105,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":35,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":35,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":84,"whyStopped":35,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Therapy (Control)","ACTIVE_COMPARATOR","Participants will receive standard conventional treatment for trauma-related Major Depressive Disorder, consisting of a stable selective serotonin reuptake inhibitor (SSRI) regimen prescribed by the treating psychiatrist. No psilocybin or Structured Integrated Reframing Therapy (SIRT) will be administered. Treatment will continue for 8 weeks with routine clinical follow-up.",[13],"Drug: Selective Serotonin Reuptake Inhibitor (SSRI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Psilocybin Therapy","EXPERIMENTAL","Participants will continue standard SSRI therapy and receive oral psilocybin administered under medical supervision in a controlled clinical setting. Two supervised dosing sessions will be conducted during the 8-week intervention period according to the study protocol. No SIRT will be provided.",[19,13],"Drug: Psilocybin",{"label":21,"type":16,"description":22,"interventionNames":23},"Structured Integrated Reframing Therapy (SIRT)","Participants will continue standard SSRI therapy and receive Structured Integrated Reframing Therapy (SIRT), a trauma-informed psychotherapy integrating Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), mindfulness, cognitive reframing, and communication-focused therapeutic techniques. Therapy will be delivered once weekly for 8 weeks by trained therapists.",[24,13],"Behavioral: Structured Integrated Reframing Therapy (SIRT)",{"label":26,"type":16,"description":27,"interventionNames":28},"Psilocybin-Assisted Structured Integrated Reframing Therapy","Participants will continue standard SSRI therapy and receive both supervised oral psilocybin administration and Structured Integrated Reframing Therapy (SIRT). Psilocybin will be administered in two supervised dosing sessions during the 8-week intervention period, while SIRT will be delivered once weekly for 8 weeks. The combined intervention is intended to evaluate the synergistic effects of psychedelic-assisted psychotherapy on clinical outcomes and gut-brain axis biomarkers.",[19,24,13],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Psilocybin","Oral psilocybin administered under medical supervision in a controlled clinical setting. Participants assigned to psilocybin-containing arms will receive two supervised dosing sessions during the 8-week intervention period in addition to stable standard antidepressant therapy. The dosage and administration procedures will follow the approved study protocol.",[15,26],null,{"type":37,"name":21,"description":38,"armGroupLabels":39,"otherNames":35},"BEHAVIORAL","Structured Integrated Reframing Therapy (SIRT) is a trauma-informed psychotherapy integrating evidence-based components of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), mindfulness, cognitive reframing, emotional regulation, coping skills training, and communication-focused therapeutic techniques. Therapy is delivered once weekly for 8 weeks by trained therapists.",[26,21],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Selective Serotonin Reuptake Inhibitor (SSRI)","Participants in all study arms will continue a stable prescribed selective serotonin reuptake inhibitor (SSRI) regimen throughout the study. Participants must have been receiving the same antidepressant for at least 6 weeks before enrollment with adequate treatment adherence. Medication adjustments will be made only if clinically indicated.",[9,15,26,21],[45],"Standard antidepressant therapy",[47,51,55],{"name":48,"affiliation":49,"role":50},"Dr Omer Malik, PhD","Khyber Medical University Peshawar, Pakistan","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":53,"role":54},"Dr Inayat Shah, PhD*","Khyber Medical University","STUDY_CHAIR",{"name":56,"affiliation":53,"role":50},"Naveeda Sarwar, PhD",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":35,"email":62},"Bushra Riaz, PhD*","CONTACT","+92 3338000744","bushrariaz098@gmail.com",{"name":64,"role":60,"phone":65,"phoneExt":35,"email":66},"Dr Owais Qaiser, PhD*","+92 3139625788","drowaisqaisar.ibms@kmu.edu.pk",[68,82,99],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":35},"Institute of Health Science, Khyber Medical University","ACTIVE_NOT_RECRUITING","Islamabad","Capital","25000","Pakistan","PK",{"type":77,"coordinates":78},"Point",[79,80],73.04329,33.72148,{"lat":80,"lon":79},{"facility":83,"status":84,"city":85,"state":86,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hayatabad Medical Complex Peshawar","RECRUITING","Peshawar","KPK",{"type":77,"coordinates":88},[89,90],71.57849,34.008,{"lat":90,"lon":89},[93,95,98],{"name":64,"role":60,"phone":94,"phoneExt":35,"email":66},"+92 313 9625788",{"name":48,"role":60,"phone":96,"phoneExt":35,"email":97},"+92 333 5196243","omermalik@kmu.edu.pk",{"name":64,"role":50,"phone":35,"phoneExt":35,"email":35},{"facility":53,"status":70,"city":85,"state":86,"zip":35,"country":74,"countryCode":75,"cosmosGeoPoint":100,"geoPoint":102,"contacts":35},{"type":77,"coordinates":101},[89,90],{"lat":90,"lon":89},{"type":104,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[106,109],{"name":107,"class":108},"Hayatabad Medical Complex","OTHER_GOV",{"name":110,"class":111},"KMU Institute of Health Science, Islamabad","UNKNOWN","100645471","phase-3-effect-of-psilocybin-and-structured-integrated-reframing-therapy-on-gut-brain-axis-biomarkers-and-depression-in-major-depressive-disorder-100645471",false,"NCT07703722","Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder","Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Trauma-Related Major Depressive Disorder: Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18-60 years.\n* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria.\n* Trauma-related depression with clinically significant trauma symptoms.\n* Hamilton Depression Rating Scale (HAM-D) score \\>16.\n* PTSD Checklist for DSM-5 (PCL-5) score \\>33.\n* Generalized Anxiety Disorder-7 (GAD-7) score \\>10.\n* Receiving a stable single SSRI antidepressant regimen for at least 6 weeks before enrollment with adequate treatment adherence.\n* Able and willing to provide written informed consent.\n* Willing to comply with all study procedures and follow-up visits.\n* Women of childbearing potential must agree to use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Significant cardiovascular disease.\n* Clinically significant hepatic or renal impairment.\n* Significant neurological disorders.\n* Current or past psychotic disorder or bipolar disorder.\n* Current substance or alcohol use disorder, including ketamine or psychedelic drug use.\n* Use of more than one antidepressant medication.\n* Pregnancy, planned pregnancy, or breastfeeding.\n* Known hypersensitivity or contraindication to psilocybin.\n* Participation in another interventional clinical trial within the previous 30 days.\n* Inability or unwillingness to provide informed consent.\n* Any medical or psychiatric condition that, in the investigator's opinion, would interfere with safe participation or study assessments.","ALL","18 Years","60 Years",{"count":123,"type":124},60,"ESTIMATED","INTERVENTIONAL",[127],"PHASE3","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.\n\nThis 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.",[130,131],"Major Depressive Disorder","Post-Traumatic Stress Disorder (PTSD)",[32,133,134,135,136],"TADE Tool","Trauma","Biomarkers","Randomized Controlled Trial","2026-07-12",{"date":139,"type":140},"2026-07-14","ACTUAL",{"date":142,"type":140},"2026-04-01",{"date":144,"type":124},"2027-11-22",{"name":5,"class":6},3]