Schizophrenia / Schizoaffective DisorderMZvyagintsevNCT07876089
Validation and Comparative Multi-Omics Benchmarking of Fluid-Derived Volatilomics Biomarkers for the Prevention and Early Detection of Schizophrenia
An observational study of Schizophrenia / Schizoaffective Disorder, run by University Hospital, Aachen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia / Schizoaffective Disorder
- How many people
- 3,692 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2026to 30 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- Age: 16-55 years
- Diagnosis based on DSM-5 criteria
- Informed Written Consent
- Healthy Controls and Relatives of Patients with SZ and BP
Who cannot join
- Actual Suicidality
- Cognitive Impairment
- Eating Disorder
- Any Current Mental Health Condition or History of Major Mental Health Disorder for Healthy Controls and Relatives
- Severe Internal Disorders for Healthy Controls
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychiatry & Psychotherapy, Universitiy Hospital of RWTH Aachen, Aachen, Germany
Aachen, North Rhine-Westphalia, 52074
About this study
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.
Read the detailed description
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.
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Keywords
- volatilomics, VOCs, Schizophrenia, Depression, Early diagnostics, mulitomics
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Patients with schizophrenia spectrum | |
| Depression | Patients with major depression | |
| Healthy | Healthy volunteers | |
| Relatives | Healthy relatives of patients | |
| Preschizophrenia | Patients with clinical diagnosis which do not fulfil the schizophrenia diagnostic criteria | |
| Highriskschizophrenia | Clinical High Risk Group of Scizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis DSM-V
Diagnosis Criteria according DSM-V clinical psychiatric Interview
Measured: up to 30 months follow-up
Secondary outcomes (5)
PBRS
Brief Psychiatric Rating Scale
Measured: up to 30 months follow-up
MADRS
Montgomery-Asberg Depression Rating Scale
Measured: up to 30 months follow-up
PANSS
Positive and Negative Syndrome Scale
Measured: up to 30 months follow-up
PSYCHS
Structured Interview for Prodromal Syndromes
Measured: up to 30 months follow-up
Multiomics
Multiomics (transcriptomics) using the schizophrenia / depression panel
Measured: once - by the study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start5 Mar 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia / Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,692 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Mikhail Zvyagintsev, University Hospital, Aachen
- Investigators
- Hossam Haick, Professor, Study chair, Department of Chemical Engineering, Biomedical Engineering & The Russell Berrie Nanotechnology Institute (RBNI) Technion - Israel Institute of Technology, Haifa 32000003, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876089
- Sponsor's protocol ID
- VOLABIOS
- Acronym
- MZvyagintsev
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No