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Clinical deep phenotyping of treatment response in schizophrenia (CDP-STAR): design and methodology of a prospective
Vladislav Yakimov1,2,3, Lara Neuwinger4, Madeleine M Weber4
1Department of Psychiatry and Psychotherapy, LMU University Hospital, LMU Munich, Nussbaumstrasse 7, 80336, Munich, Germany. V.Yakimov@med.uni-muenchen.de.
Abstract:
Schizophrenia spectrum disorders (SSDs) exhibit a marked heterogeneity in clinical course and treatment outcomes. Some individuals achieve remission and recovery, whereas others experience repeated relapses and progressive deterioration in psychosocial functioning. This variability underscores the unmet clinical need for prognostic biomarkers to predict treatment outcomes and guide personalized care. Deep phenotyping with multimodal data integration holds promise for understanding this complexity and delivering clinically relevant predictive models of treatment response in SSDs. To address this need, we initiated the Clinical Deep Phenotyping of Treatment Response in Schizophrenia (CDP-STAR) study, a prospective, naturalistic, longitudinal observational study integrating comprehensive multimodal assessments. These include clinical phenotyping, magnetic resonance imaging (MRI), electroencephalography (EEG), retinal imaging, and extensive sampling of blood and cerebrospinal fluid (CSF) for multi-omics profiling. The study aims to externally validate promising biomarker candidates and elucidate the pathophysiological mechanisms underlying treatment outcomes. This innovative deep phenotyping framework integrates data across multiple critical domains, enabling external validation of potential biomarkers and the discovery of novel ones. Ultimately, the CDP-STAR study aims to yield mechanistic insights that advance precision psychiatry and inform clinical decision-making in SSDs.
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