An observational study in Schizophrenia / Schizoaffective Disorder, sponsored by University Hospital, Aachen. Active, not recruiting at 1 site in Germany. Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University Hospital, Aachen · Observational
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.
VOLABIOS is centred around addressing the major challenges faced in the diagnosis and management of schizophrenia (SZ), with the aim of achieving more efficient and effective results through validated biomarkers and innovative technologies. SZ is a complex brain disorder that poses a high global burden and is characterized by diverse symptoms, impairments, and biological causes. The current diagnostic methods are hampered by the absence of objective biomarkers, leading to delays and inaccuracies in diagnosis. In the first months of psychosis the outcome is unclear and these early psychosis stages (hereafter abbreviated by pre-SZ, since at the stage of data collection the illness outcome and diagnosis is clinically visible, yet) may reveal to brief psychotic episodes, acute transient psychosis, schizophreniforme disorder or SZ. This lack of early diagnosis and intervention severely impacts patient outcomes and contributes to the progression and increased disability of the disorder. The goal of VOLABIOS is to revolutionize the diagnosis and monitoring of SZ by utilizing volatilomics, a novel, minimally invasive approach focused on detecting and analysing Volatile Organic Compounds (VOCs) present in bodily fluids. This methodology promises to be more efficient and accessible in identifying SZ early on, addressing the limitations of current diagnostic practices that rely heavily on subjective assessments and lack specificity. VOLABIOS will conduct a comprehensive study involving 3692 patients and controls across six European clinical centres to validate the efficacy and nature of VOCs in supporting early diagnosis of SZ. By integrating validated VOCs with genomics, proteomics, and transcriptomics data, VOLABIOS aims to develop a deeper understanding of the disorder, which will facilitate the creation of effective diagnostic tools capable of detecting the disorder at an early stage. In addition, VOLABIOS aims to improve diagnostic outcomes by analysing a vast dataset of retrospective population records and examining correlations with various risk factors, lifestyle choices, and other disorders that share symptoms with SZ. This holistic approach ensures the robustness of identified VOC biomarkers and their relevance to SZ diagnosis and monitoring. The project also plans to explore the potential of computational drug repurposing and pharmacogenomics approaches for personalized treatment and management of SZ, highlighting its commitment to advancing personalized medicine. Moreover, VOLABIOS emphasizes the creation of Value-Based Care Models (VBCM) and a centralized protocol for diagnosing SZ in the EU, reflecting its dedication to enhancing patient care and the efficiency of healthcare systems. With the support of key stakeholders, including Ministries of Health and influential policy makers, VOLABIOS is well-positioned to lead the adoption of validated VOC biomarkers and innovative technologies, significantly improving patient outcomes and the overall quality of healthcare for individuals with SZ. In summary, VOLABIOS is a ground-breaking initiative that will have far-reaching implications in the field of SZ diagnosis and management.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's planned enrollment of 3,692 is above the median of 178 across 503 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →University Hospital, Aachen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are from the Hosptial. Relatives are the realtives of these patients. Healthy volunteers will be acquired from public advertisement. Pre-SZ and CHR patients are from Prodrom Ambulance or from the clinic or from the Mental Health Centres within the University Hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with schizophrenia spectrum
Patients with major depression
Healthy volunteers
Healthy relatives of patients
Patients with clinical diagnosis which do not fulfil the schizophrenia diagnostic criteria
Clinical High Risk Group of Scizophrenia
Diagnosis DSM-V
Diagnosis Criteria according DSM-V clinical psychiatric Interview
Time frame: up to 30 months follow-up
PBRS
Brief Psychiatric Rating Scale
Time frame: up to 30 months follow-up
MADRS
Montgomery-Asberg Depression Rating Scale
Time frame: up to 30 months follow-up
PANSS
Positive and Negative Syndrome Scale
Time frame: up to 30 months follow-up
PSYCHS
Structured Interview for Prodromal Syndromes
Time frame: up to 30 months follow-up
Multiomics
Multiomics (transcriptomics) using the schizophrenia / depression panel
Time frame: once - by the study inclusion
VOC
volatilomic organic components
Time frame: up to 30 months follow-up
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Aachen