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Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia

Recruitingn/aAges 18 Years - 70 YearsAllMedical University Innsbruck
NCT07856381 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time. Two groups will take part in the study: 1. people diagnosed with schizophrenia 2. healthy adults without schizophrenia Participants 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. The study includes three assessment visits: 1. Baseline: at the beginning of the study 2. 12-month follow-up: approximately one year later 3. 24-month follow-up: approximately two years later At all three visits, participants will complete behavioral tests and questionnaires, and blood and hair samples will be co

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📋 Eligibility rules (as published)
Inclusion criteria (all participants): age 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. Inclusion criteria (SZ only): clinical 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. Exclusion criteria (all participants): incapacity 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. Exclusion criteria (HC only): any 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. Additional Eligibility Criteria for Cycle-Timed Neuroimaging: To 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. Use of hormonal contraception will be recorded.
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What it tests

  • Not listed
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Where

1 site
Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology; Medical University of Innsbruck
Innsbruck, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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