[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658601":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":68,"armGroups":69,"interventions":64,"overallOfficials":64,"centralContacts":76,"locations":82,"responsibleParty":102,"collaborators":106,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":64,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":64,"studyType":125,"phases":64,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":85,"whyStopped":64,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":64},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change in Theory of Mind performance","Theory of Mind will be assessed using the EmpaToM task. The outcome will include performance-based indices of cognitive and affective Theory of Mind. Higher scores indicate better ability to infer and understand the mental states of others.","Baseline, 12 months, and 24 months",{"measure":14,"description":15,"timeFrame":12},"Change in attributional style","Attributional style will be assessed using the Internal, Personal and Situational Attributions Questionnaire-Revised. The outcome will measure tendencies to attribute positive and negative social events to internal, personal-external, or situational-external causes; aswell as monocausal-inference-style.",{"measure":17,"description":18,"timeFrame":12},"Change in emotion recognition performance","Emotion recognition will be assessed using the DiagnosIS Emotion Recognition Task. The outcome will measure accuracy in identifying facial emotional expressions. Higher scores indicate better emotion recognition performance.",{"measure":20,"description":21,"timeFrame":22},"Change in Emotion Regulation Choice","The Emotion Regulation Choice Task is a behavioral paradigm used to examines whether individuals adapt their choice of emotion regulation strategy according to the intensity of negative emotional stimuli.\n\nIt will be used to assess the change in the degree to which strategy choice changes as a function of emotional intensity.","Baseline, 12 months, 24 months",[24,27,30,33,36,40,43,46,49,52,55,58,61],{"measure":25,"description":26,"timeFrame":12},"Change in reflective functioning","Reflective functioning will be assessed using the Reflective Functioning Questionnaire. The outcome will measure certainty and uncertainty about mental states. Scores will be analyzed according to the scoring rules of the instrument.",{"measure":28,"description":29,"timeFrame":22},"Change in self reported Emotion Regulation","Self reported emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ). The ERQ is a 10-item self-report measure assessing the habitual use of two emotion-regulation strategies: cognitive reappraisal and expressive suppression.",{"measure":31,"description":32,"timeFrame":12},"Change in global cognitive functioning","Global cognition will be assessed using the Screen for Cognitive Impairment in Psychiatry. The outcome will provide a standardized measure of cognitive functioning across domains including verbal learning, working memory, verbal fluency, and processing speed. Higher scores indicate better cognitive performance.",{"measure":34,"description":35,"timeFrame":12},"Change in daily functioning and disability","Daily functioning and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0. The outcome will measure functioning across cognition, mobility, self-care, interpersonal relationships, life activities, and participation in society. Higher scores indicate greater disability.",{"measure":37,"description":38,"timeFrame":39},"Change in brain iron distribution measured by quantitative susceptibility mapping","Brain iron distribution will be assessed using quantitative susceptibility mapping (QSM) derived from multi-echo gradient echo MRI.","Baseline and 12 months",{"measure":41,"description":42,"timeFrame":39},"Change in R2* relaxometry measures of brain iron-sensitive signal","R2\\* values will be derived from multi-echo gradient echo MRI as an iron-sensitive neuroimaging measure.",{"measure":44,"description":45,"timeFrame":39},"Change in white matter microstructure","White matter microstructure will be assessed using diffusion-weighted MRI. Outcomes will include fractional anisotropy, mean diffusivity, radial diffusivity, and axial diffusivity.",{"measure":47,"description":48,"timeFrame":39},"Change in resting-state functional connectivity","Resting-state functional connectivity will be assessed using resting-state functional MRI.",{"measure":50,"description":51,"timeFrame":12},"Change in extracellular vesicle-derived redox markers","Neuronally derived extracellular vesicles will be isolated from plasma samples.",{"measure":53,"description":54,"timeFrame":12},"Change in hair proteomic signatures","Hair samples will be analyzed using untargeted proteomic profiling. Outcomes will include proteomic signature related to oxidative stress, antioxidant defense, inflammation, mitochondrial bioenergetics, systemic stress, and biological aging.",{"measure":56,"description":57,"timeFrame":12},"Change in hair cortisol concentration","Hair cortisol concentration will be measured from scalp hair samples as an index of cumulative hypothalamic-pituitary-adrenal axis activity over the preceding months. Higher values indicate higher cumulative cortisol exposure.",{"measure":59,"description":60,"timeFrame":12},"Change in psychopathological symptom severity","Psychopathological symptoms in participants with schizophrenia will be assessed using the Positive and Negative Syndrome Scale. The outcome will include total and subscale scores for positive symptoms, negative symptoms, and general psychopathology. Higher scores indicate greater symptom severity.",{"measure":62,"description":63,"timeFrame":12},"Change in negative symptom severity","Negative symptoms will be assessed using the Brief Negative Symptom Scale. The outcome will measure negative symptom domains including anhedonia, asociality, avolition, blunted affect, and alogia. Higher scores indicate greater negative symptom severity.",null,{"allocation":64,"interventionModel":64,"interventionModelDescription":64,"primaryPurpose":64,"observationalModel":66,"timePerspective":67,"maskingInfo":64},"COHORT","PROSPECTIVE","Participants with SZ will be recruited through multiple clinical pathways to ensure adequate sample size and representativeness across the adult lifespan. The primary recruitment source is the specialized outpatient clinic for SZ spectrum disorders at the Department of Psychiatry, MUI, which serves a large catchment area and maintains detailed diagnostic records. Additional participants will be recruited through a collaborating psychiatric hospital and office-based psychiatrists and psychosocial service providers in the region, with whom the Dep. of Psychiatry maintains established referral networks. Patients in the SZ group must have a DSM-5 diagnosis of schizophrenia confirmed by their treating psychiatrist. HC participants will be recruited through advertisements in online platforms, social media, and community outreach.",[70,73],{"label":71,"type":64,"description":72,"interventionNames":64},"Schizophrenia Group","Group of people with a diagnosis of schizophrenia confirmed by their treating psychiatrist.",{"label":74,"type":64,"description":75,"interventionNames":64},"Healthy control group","Group absent of any Axis-I Diagnosis",[77],{"name":78,"role":79,"phone":80,"phoneExt":64,"email":81},"Christopher Schaar, M.Sc.","CONTACT","0043 512 9003 81298","christopher.schaar@i-med.ac.at",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology; Medical University of Innsbruck","RECRUITING","Innsbruck","Tyrol","6020","Austria","AT",{"type":92,"coordinates":93},"Point",[94,95],11.39454,47.26266,{"lat":95,"lon":94},[98],{"name":99,"role":79,"phone":100,"phoneExt":64,"email":101},"Alexandra Schlögl","0043 50 504 23669","alexandra.schloegl@tirol-kliniken.at",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"PRINCIPAL_INVESTIGATOR","Beatrice Frajo-Apor","M.D., PhD.",[107,109],{"name":108,"class":6},"Technische Universität Dresden",{"name":110,"class":6},"University of Innsbruck, Austria","100658601","understanding-lifespan-trajectories-of-social-cognition-brain-microstructure-and-iron-dysregulation-in-schizophrenia-100658601",false,"NCT07856381","Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia","SilverMinds - Lifespan Trajectories of Social Cognition and Iron Dysregulation in Schizophrenia","Inclusion criteria (all participants):\n\nage 18-70 years at baseline; normal or corrected-to-normal vision; sufficient hearing; fluency in German; willingness and ability to understand and comply with study procedures. Participants must either be healthy adults without any mental health disorder (HC) or have a confirmed DSM-5 diagnosis of SZ.\n\nInclusion criteria (SZ only):\n\nclinical stability at assessment, defined as no clinically significant change in psychopathological symptoms and no modification of pharmacotherapy for at least three months prior to study entry, as confirmed by the treating psychiatrist; full remission is not required.\n\nExclusion criteria (all participants):\n\nincapacity to consent; current or lifetime history of brain surgery or epilepsy; MRI contraindications (unremovable metal parts in the upper body, active implants, claustrophobia); current or past substance abuse disorder (excluding caffeine and nicotine); pregnancy.\n\nExclusion criteria (HC only):\n\nany current or lifetime Axis I psychiatric disorder; first-degree relative with an Axis I disorder; any neurological disorder or other mental health condition; current or past use of psychotropic medication.\n\nAdditional Eligibility Criteria for Cycle-Timed Neuroimaging:\n\nTo minimize hormonal confounding of emotion-regulation-related neural measures, menstruating female participants will be scanned in the early follicular phase (cycle days 1-6), requiring regular menstrual cycles (21-35 days) and a negative pregnancy test at relevant visits.\n\nUse of hormonal contraception will be recorded.",true,"ALL","18 Years","70 Years",{"count":123,"type":124},180,"ESTIMATED","OBSERVATIONAL","This study aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time.\n\nTwo groups will take part in the study:\n\n1. people diagnosed with schizophrenia\n2. healthy adults without schizophrenia\n\nParticipants in both groups will complete a series of behavioral tasks and questionnaires. These will assess abilities such as understanding other people, processing social information, and regulating emotions. For participants with schizophrenia, we will also assess clinical symptoms and their severity.\n\nThe study includes three assessment visits:\n\n1. Baseline: at the beginning of the study\n2. 12-month follow-up: approximately one year later\n3. 24-month follow-up: approximately two years later\n\nAt all three visits, participants will complete behavioral tests and questionnaires, and blood and hair samples will be collected. These samples may help researchers investigate biological factors that are related to mental health, stress, and changes over time.\n\nParticipants will also undergo an MRI brain scan at the baseline visit and again at the 12-month follow-up.\n\nPeople with schizophrenia may experience changes in thinking, emotions, social functioning, physical health, and brain function across adulthood. However, we still do not fully understand how these changes develop over time or how they differ from normal aging.\n\nBy comparing people with schizophrenia with healthy adults of different ages and following them over time, we can study possible differences in aging trajectories. This means examining whether certain abilities, symptoms, biological markers, or brain characteristics change differently with age in people with schizophrenia.\n\nThe study uses an accelerated longitudinal design. Instead of following one group of people for many decades, researchers recruit participants from different age groups and follow them for a shorter period. Combining information across these age groups can help researchers estimate longer-term patterns of change.",[128,129],"Healthy Control Subjects","Schizophrenia Diagnosis",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"schizophrenia","social cognition","Brain iron","accelerated longitudinal design","age trajectory","lifespan","Cognitive Dysfunction","Longitudinal Studies","Magnetic Resonance Imaging","Quantitative Susceptibility Mapping","Extracellular Vesicles","Oxidative Stress","Redox Regulation","Glutathione","Hair Proteomics","Psychosocial Functioning","Negative Symptoms","Theory of Mind","Emotion Recognition","Emotion Regulation","Attributional Style","NDEV","functional outcome","2026-09-23",{"date":156,"type":157},"2026-10-02","ACTUAL",{"date":159,"type":157},"2026-09-01",{"date":161,"type":124},"2030-09-30",{"name":5,"class":6},1]