[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649449":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":24,"responsibleParty":44,"collaborators":46,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shanghai Mental Health Center","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Major Depressive Disorder (MDD) Cohort",null,"Participants with major depressive disorder (MDD) aged 14-45 years will be enrolled in this cohort. Participants will undergo standardized clinical assessments, biological sample collection, and longitudinal follow-up during antidepressant treatment. Clinical data and biological samples will be collected at predefined time points for multi-omics profiling, including genomics, transcriptomics (bulk and single-cell), proteomics, metabolomics, immune cell phenotyping, and gut microbiome analyses, among others.",{"label":13,"type":10,"description":14,"interventionNames":10},"Healthy Control (HC) Cohort","Healthy participants aged 14-45 years will be enrolled as a comparison cohort. Participants will undergo baseline clinical assessments and biological sample collection for comparison with individuals with major depressive disorder.",[16],{"name":17,"affiliation":5,"role":18},"Shen He","PRINCIPAL_INVESTIGATOR",[20],{"name":17,"role":21,"phone":22,"phoneExt":10,"email":23},"CONTACT","+86 18817314682","shenhe0204@126.com",[25],{"facility":5,"status":10,"city":26,"state":10,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Shanghai","200030","China","CN",{"type":31,"coordinates":32},"Point",[33,34],121.45806,31.22222,{"lat":34,"lon":33},[37,40,43],{"name":38,"role":21,"phone":39,"phoneExt":10,"email":23},"Shen He, Dr.","02134773128",{"name":41,"role":21,"phone":10,"phoneExt":10,"email":42},"He","shenhe@smhc.org.cn",{"name":38,"role":18,"phone":10,"phoneExt":10,"email":10},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[47],{"name":48,"class":6},"LinGang Laboratory","100649449","imore-study-a-multi-omics-cohort-study-of-major-depressive-disorder-100649449",false,"NCT07735143","iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder","iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling","iMORE+","Inclusion Criteria:\n\nGeneral criteria:\n\n* Participants aged 14-45 years.\n* Participants are able to understand the study procedures and provide written informed consent. For participants younger than 18 years, both the participant and their legal guardian must provide consent.\n\nMajor Depressive Disorder (MDD) cohort:\n\n* Meet DSM-5 criteria for major depressive disorder (single or recurrent episode).\n* Have a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18.\n\nHealthy Control (HC) cohort:\n\n\\- Healthy participants without a current or lifetime diagnosis of major psychiatric disorders.\n\nExclusion Criteria:\n\nFor all participants:\n\n\\- Severe or unstable medical conditions, pregnancy or breastfeeding, or other conditions considered unsuitable for study participation.\n\nFor the MDD cohort:\n\n* Current or lifetime diagnosis of other major psychiatric disorders, including schizophrenia spectrum disorders, schizoaffective disorder, or bipolar disorder.\n* Substance use disorder within 12 months prior to screening.\n* Depression secondary to medical or neurological conditions.\n* Regular antidepressant treatment within 2 weeks prior to enrollment.\n* Electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagus nerve stimulation (VNS), or immunosuppressive therapy during the current depressive episode.\n* Current active suicidal plan or recent suicidal behavior considered unsuitable for participation.\n\nFor the HC cohort:\n\n* Current or lifetime diagnosis of any psychiatric disorder.\n* Significant depressive, anxiety, manic, or psychotic symptoms.\n* Previous treatment with antidepressants, antipsychotics, or mood stabilizers.\n* Significant family history of major psychiatric disorders.",true,"ALL","14 Years","45 Years",{"count":62,"type":63},150,"ESTIMATED","1 Year","OBSERVATIONAL","Major depressive disorder (MDD) is a common mental health condition characterized by substantial clinical heterogeneity and variability in treatment response. Current diagnosis and treatment selection for MDD mainly rely on clinical assessments, and reliable biological markers that can support diagnosis, predict antidepressant treatment response, guide personalized treatment, and improve understanding of disease mechanisms remain limited.\n\nThe goal of this prospective observational cohort study is to develop and optimize multi-omics-based models for MDD diagnosis and antidepressant treatment response prediction using longitudinal clinical characteristics and biological data collected from an independent prospective cohort. The study also aims to evaluate the generalizability and predictive performance of existing multi-omics-based models in this independent cohort of participants aged 14-45 years.\n\nThe main questions it aims to answer are:\n\nCan integrated clinical and multi-omics features identify biomarkers and develop predictive models for MDD diagnosis and antidepressant treatment response? Can existing multi-omics-based models for MDD diagnosis and treatment response prediction be replicated and validated in an independent prospective cohort?\n\nParticipants with MDD and healthy controls will undergo standardized clinical assessments, longitudinal follow-up, and biological sample collection for multi-omics profiling. Clinical and multi-omics data will be integrated to identify biomarkers, develop and validate predictive models for MDD diagnosis, antidepressant treatment response, and long-term outcomes, and explore biological pathways and potential therapeutic targets associated with MDD.\n\nThe study is expected to improve understanding of the biological heterogeneity of MDD and contribute to the development of objective approaches for diagnosis, treatment response prediction, personalized care, and future therapeutic discovery.",[68],"Major Depressive Disorder (MDD)","NOT_YET_RECRUITING","2026-07-30",{"date":72,"type":73},"2026-08-03","ACTUAL",{"date":75,"type":63},"2027-09-01",{"date":77,"type":63},"2028-02-01",{"name":5,"class":6},1]