[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643022":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":10,"centralContacts":40,"locations":46,"responsibleParty":137,"collaborators":10,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":10,"studyType":156,"phases":10,"briefSummary":157,"conditions":158,"keywords":10,"overallStatus":164,"whyStopped":10,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"University of Catania","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Major Depressive Disorder Cohort",null,"Drug-naïve or drug-free patients diagnosed with Major Depressive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).",[13],"Genetic: Reverse Transcription Quantitative Polymerase Chain Reaction",{"label":15,"type":10,"description":16,"interventionNames":17},"Schizophrenia Cohort","Drug-naïve or drug-free patients diagnosed with Schizophrenia, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Obsessive-Compulsive Disorder Cohort","Drug-naïve or drug-free patients diagnosed with Obsessive-Compulsive Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Panic Disorder Cohort","Drug-naïve or drug-free patients diagnosed with Panic Disorder, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Bipolar Disorder Cohort","Drug-naïve or drug-free patients diagnosed with Bipolar Disorder type I or II, assessed at baseline (T0) and after at least five months of standard pharmacological treatment (T1).",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Healthy Control Cohort","Healthy volunteers without current psychiatric disorders or psychotropic medication use, assessed at baseline only.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"GENETIC","Reverse Transcription Quantitative Polymerase Chain Reaction","Gene expression analysis of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR).",[27,31,9,19,23,15],[41],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Professor Maria Salvina Signorelli, PhD, MD","CONTACT","+39 095 3782791","maria.signorelli@unict.it",[47,75,89,111,121],{"facility":48,"status":10,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Psychiatry Unit, Via Santa Sofia 78","Catania","Sicily","95123","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],15.07041,37.49223,{"lat":58,"lon":57},[61,62,65,67,69,71,73],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Fabrizio Bella, MD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Antonino Petralia, PhD, MD",{"name":68,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Carmen Concerto, PhD, MD",{"name":70,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Ludovico Mineo, PhD, MD",{"name":72,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Lucia Basile, MD",{"name":74,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Cinzia Santa Di Pietro, PhD",{"facility":76,"status":10,"city":77,"state":50,"zip":78,"country":52,"countryCode":53,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Psychiatry Unit, Contrada Ferrante SNC","Enna","94100",{"type":55,"coordinates":80},[81,82],14.27433,37.5655,{"lat":82,"lon":81},[85],{"name":86,"role":43,"phone":87,"phoneExt":10,"email":88},"Professor Antonino Messina, PhD, MD","+39 0935 516044","antonino.messina2@unikore.it",{"facility":90,"status":10,"city":91,"state":50,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Cellular and Molecular Biology Laboratory, Tower of Biological Laboratories, 5th Floor Via Consolare Valeria 1","Messina","98125",{"type":55,"coordinates":94},[95,96],15.55256,38.19394,{"lat":96,"lon":95},[99,103,105,107,109],{"name":100,"role":43,"phone":101,"phoneExt":10,"email":102},"Professor Angela D'Ascola, PhD","+39 090 221 3389","adascola@unime.it",{"name":104,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Michele Scuruchi, PhD",{"name":106,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Salvatore Campo, PhD",{"name":108,"role":64,"phone":10,"phoneExt":10,"email":10},"Professor Giuseppe Maurizio Campo, PhD",{"name":110,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Angela Avenoso, PhD",{"facility":112,"status":10,"city":91,"state":50,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Psychiatry Unit, Via Consolare Valeria 1",{"type":55,"coordinates":114},[95,96],{"lat":96,"lon":95},[117],{"name":118,"role":43,"phone":119,"phoneExt":10,"email":120},"Professor Maria Rosaria Anna Muscatello, PhD, MD","+39 090 2217384","maria.muscatello@unime.it",{"facility":122,"status":10,"city":123,"state":50,"zip":124,"country":52,"countryCode":53,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Psychiatry Unit, Via del Vespro 129","Palermo","90127",{"type":55,"coordinates":126},[127,128],13.3636,38.1166,{"lat":128,"lon":127},[131,135],{"name":132,"role":43,"phone":133,"phoneExt":10,"email":134},"Professor Diego Quattrone, PhD, MD","+39 091 238 93011","diego.quattrone@unipa.it",{"name":136,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Giovanna Marrazzo, PhD, MD",{"type":138,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Carmen Concerto","Clinical Professor","100643022","non-coding-rnas-gene-expression-in-psychiatric-disorders-100643022",false,"NCT07649993","Non-Coding RNAs Gene Expression in Psychiatric Disorders","Gene Expression Analysis of Non-coding RNAs in Psychiatric Disorders","PsiRNA26","Inclusion Criteria (patients):\n\n* Age between 18 and 55 years;\n* Male sex or female sex in the mid-luteal phase of the menstrual cycle;\n* Clinical presentation consistent with diagnostic criteria for:\n* Bipolar Disorder type I or II,\n* Panic Disorder,\n* Major Depressive Disorder,\n* Obsessive-Compulsive Disorder,\n* Schizophrenia;\n* First diagnosis and drug-naive status, or absence of psychopharmacological treatment for at least 6 months prior to enrollment.\n\nInclusion Criteria (Healthy Control):\n\n* Age between 18 and 55 years;\n* Male sex or female sex in the mid-luteal phase of the menstrual cycle;\n* No treatment with psychotropic medications;\n* Absence of clinical elements supporting a diagnosis of Bipolar Disorder, Panic Disorder, Major Depressive Disorder, Obsessive-Compulsive Disorder, Schizophrenia;\n* Absence of clinical or laboratory evidence of infectious or internal medicine diseases;\n* Absence of autoimmune diseases;\n* HAM-D score \\\u003C 8;\n* MRS score \\\u003C 11;\n* Y-BOCS score \\\u003C 7;\n* BPRS score = 18;\n* No significant stressful life events during the previous 6 months.\n\nExclusion Criteria (patients):\n\n* Current immunosuppressive, antibiotic, or hormone replacement therapy;\n* Relevant medical comorbidities, including autoimmune or internal medicine disorders;\n* Active infectious diseases or infections resolved less than 3 weeks before enrollment;\n* Relevant psychiatric comorbidities;\n* Current psychopharmacological treatment or discontinuation of psychopharmacological therapy less than 6 months before enrollment.",true,"ALL","18 Years","55 Years",{"count":154,"type":155},384,"ESTIMATED","OBSERVATIONAL","This study aims to investigate whether specific non-coding RNAs, molecules involved in the regulation of gene expression, are altered in individuals with psychiatric disorders such as schizophrenia, bipolar disorder, major depressive disorder, panic disorder, and obsessive-compulsive disorder. Researchers will compare the expression levels of these molecules in patients who are drug-naïve or have been free from psychiatric treatment for at least six months with those observed in healthy volunteers.\n\nThe study will also evaluate whether the expression of these non-coding RNAs changes after approximately five months of standard psychiatric treatment. Blood samples collected during routine clinical care will be used to measure the expression levels of selected non-coding RNAs using reverse transcription quantitative polymerase chain reaction (RT-qPCR), a laboratory technique used to assess gene expression.\n\nThis is an observational study and does not assign specific treatments. All therapies will be prescribed according to standard clinical practice.\n\nThe main objective is to determine whether alterations in non-coding RNA expression may serve as biological markers of psychiatric disorders and whether these markers may help monitor treatment-related changes over time. The findings may contribute to a better understanding of the biological mechanisms underlying major psychiatric disorders and support the future development of more accurate diagnostic and therapeutic approaches.",[159,160,161,162,163],"Schizophrenia Disorders","Major Depression","Bipolar Affective Disorders","Obsessive Compulsive Disorder (OCD)","Anxiety Disorder (Panic Disorder or GAD)","NOT_YET_RECRUITING","2026-06-18",{"date":167,"type":168},"2026-06-23","ACTUAL",{"date":170,"type":155},"2026-09-01",{"date":172,"type":155},"2028-09-01",{"name":139,"class":6},5]