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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Comparative Multi-Omics Benchmarking of Fluid-Derived Volatilomics Biomarkers for the Prevention and Early Detection of Schizophrenia
- ClinicalTrials.gov ID
- NCT07876089
- Acronym / sponsor ID
- MZvyagintsev / VOLABIOS
- Conditions
- Schizophrenia / Schizoaffective Disorder
- Keywords
- volatilomics, VOCs, Schizophrenia, Depression, Early diagnostics, mulitomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,692 participants (estimated)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Age: 16-55 years
- Diagnosis based on DSM-5 criteria
- Informed Written Consent
- Healthy Controls and Relatives of Patients with SZ and BP
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis DSM-V
Time frame: up to 30 months follow-up
Diagnosis Criteria according DSM-V clinical psychiatric Interview
5 secondary outcomes
PBRS
Time frame: up to 30 months follow-up
MADRS
Time frame: up to 30 months follow-up
PANSS
Time frame: up to 30 months follow-up
PSYCHS
Time frame: up to 30 months follow-up
Multiomics
Time frame: once - by the study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia / Schizoaffective Disorder, run by University Hospital, Aachen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis DSM-V (time frame: up to 30 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.