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Life sciences · Observational Study
ClinicalTrials.gov · October 15, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07876089). This is a study registration, not published results. Lead sponsor: University Hospital, Aachen. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 3692 participants (ESTIMATED). Conditions: Schizophrenia / Schizoaffective Disorder. Primary outcome measures: Diagnosis DSM-V , up to 30 months follow-up. Brief summary: Schizophrenia (SZ) is one of the most severe and costly mental disorders in terms of human suffering and societal expenditure. Currently, there are no biomarkers that facilitate the early diagnosis of SZ. Early detection, even before the 6-month duration criteria for diagnosing SZ according to DSM-5, would be crucial for clinician's treatment decisions and patient counselling. While several biomarker candidates have been explored, including those related to neurotransmitter systems, neuroimaging findings, and genetic markers, none have been universally adopted in clinical practice as they lack predictive value. Volatilomics has demonstrated significant potential in refining diagnostic accuracy and improving patient outcomes, especially during the initial stages of SZ. Research has shown differences in Volatile Organic Compounds (VOCs) like alkanes, ethane, and butane between individuals with SZ and bipolar disorder compared to healthy people. Most important measurement of VOCs is non-invasive, not of any major hurdle to the patient and not time consuming. VOLABIOS will advance the detection and prediction of SZ through the validation and investigation of various VOCs present in different body fluids, opening a diagnostic and prognostic knowledge space within the Patient Journey to measure clinical states and outcome risks with personalised sets of multimodal and validated instruments. Central to its mission is the validation process, conducted across multi-centre trials to ensure the reliability and universal applicability of VOC-based diagnostics.