F20.0
Conditions
Interventions
Group 1: This is a multi-center, naturalistic, register study. No interventions. Following groups of participants are planned: Patients with acute Psychosis not fullfilling the SZ criteria - 610, Pati
Sponsors
EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY
Eligibility
Sex/Gender
All
Age
16 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age: 16–55 years. Diagnosis based on DSM-5 criteria Informed Written Consent. Healthy Controls and Relatives of Patients with SZ and BP.
Exclusion criteria
Exclusion criteria: Actual Suicidality Cognitive Impairment Eating Disorder Severe Internal Disorders for Healthy Controls Any Current Mental Health Condition or History of Major Mental Health Disorder for Healthy Controls and Relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to investigate the diagnostic accuracy of SZ-related VOCs derived from breath, skin, urine, and blood samples in the early diagnosis of patients with SZ even within the first 6 months after psychosis onset | — |
Secondary
| Measure | Time frame |
|---|---|
| • To study the potential of VOCs to predict the conversion from pre-SZ states and Clinical High-Risk (CHR) to fully diagnosed SZ over the full observation period, providing a tool for early intervention. • To examine from multi-omics diagnostic accuracy and prediction of conversion from pre-SZ states and CHR to SZ over the observation period. • Identify specific VOCs that are associated with the symptoms and symptom changes in SZ and MDD, aiming to uncover biomarkers that can serve as indicators of disease presence and longer disease progression. • Examine the capacity of VOC biosignatures to predict responses to therapeutic interventions and the course of illness in SZ patients over the study period, contributing to personalized treatment plans. • Investigate whether VOC biosignatures can also predict the course of illness for MDD during the study, enhancing understanding and management of MDD. • Evaluate the stability of VOCs over time to determine which are trait markers (consistent over time) versus state markers (varying with disease state), aiding in the differentiation between chronic conditions and fluctuating disease states. • Explore the mediation effect of metabolic signatures on adverse effects, aiming to link metabolic changes directly to clinical outcomes and adverse reactions. • Blind validation of the VOLABIOS Toolkit in terms of diagnostic performance, efficacy and cost effectiveness | — |
Countries
Germany, Israel, Lithuania, Portugal, Spain, United Kingdom
Contacts
Public ContactThomas Frodl
Universitätsklinikum RWTH Aachen
Outcome results
None listed