MZvyagintsevNCT07876089

Validation and Comparative Multi-Omics Benchmarking of Fluid-Derived Volatilomics Biomarkers for the Prevention and Early Detection of Schizophrenia

StatusActive, Not Recruiting

PhaseNot specified

SponsorUniversity Hospital, Aachen

Primary completionJun 30, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 8, 2026 Study First Submitted

Endpoints

Primary

Diagnosis DSM-V

Timeframe: up to 30 months follow-up

Secondary (5)

PBRS

MADRS

PANSS

PSYCHS

Multiomics

Arms and interventions

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

Sites

1 site in 1 country

Psychiatry & Psychotherapy, Universitiy Hospital of RWTH Aachen, Aachen, GermanyAachen, North Rhine-Westphalia, Germany

About this trial

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.

Trial details

Enrollment: 3,692 participants (estimated)
Started: Mar 5, 2026
Study completion: Jun 30, 2029 (estimated)
Eligibility: 16 to 55, all sexes, healthy volunteers accepted
Design: Observational
Oversight: Data monitoring committee
Conditions: Depression, Psychotic Disorders, Schizophrenia, Schizophrenia / Schizoaffective Disorder
Collaborators: European Commission
First posted: Oct 15, 2026
Registry updated: Oct 15, 2026
Last verified: Oct 2026

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