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

NCT07876089 | Active Not Recruiting DMC

• 1 other identifier: VOLABIOS
• Study Type: observational
• Target: 3,692
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia / Schizoaffective Disorder

Keywords

volatilomics; VOCs; Schizophrenia; Depression; Early diagnostics; mulitomics

Outcome Measures

Primary Outcomes (1)

• Diagnosis DSM-V

  Diagnosis Criteria according DSM-V clinical psychiatric Interview

  up to 30 months follow-up

Secondary Outcomes (5)

• PBRS

  up to 30 months follow-up

• MADRS

  up to 30 months follow-up

• PANSS

  up to 30 months follow-up

• PSYCHS

  up to 30 months follow-up

• Multiomics

  once - by the study inclusion

Other Outcomes (1)

• VOC

  up to 30 months follow-up

Study Arms (6)

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

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age: 16-55 years
• Diagnosis based on DSM-5 criteria
• Informed Written Consent
• Healthy Controls and Relatives of Patients with SZ and BP

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Aachen: lead
• European Commission: collaborator

Study Sites (1)

Psychiatry & Psychotherapy, Universitiy Hospital of RWTH Aachen, Aachen, Germany

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Hossam Haick, Professor

  Department of Chemical Engineering, Biomedical Engineering & The Russell Berrie Nanotechnology Institute (RBNI) Technion - Israel Institute of Technology, Haifa 32000003, Israel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist of the Psychiatry Clinic

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

DE (1)