Breathomics in depression: stress related changes of the exhaled breath during the early course of disease management

Breathomics in depression: stress related changes of the exhaled breath during the early course of disease management - Simply Volatile

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027920

Enrollment

240

Registered

2022-01-25

Start date

2022-10-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostik System Mental Disorders, DSM V

Interventions

Group 1: Patients will be investigated at baseline, after 2 weeks and after 4 weeks using clinical assessments (MADRS, HARS, CGI, BDI, CIRS, C-SSRS, FFQ) and breath gas analysis (at awakening, after 3

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: MDD according to DSM-V, a MADRS depression severity score of larger than 26 and age between 18 and 65 years.

Exclusion criteria

Exclusion criteria: Excluded will be patients with a current depressive episode with psychotic symptoms, and suicidal intend. Moreover, subjects with a known alcohol or drug dependency will be excluded. Neurological disorders and diseases affecting the brain function will further be excluded (e.g. manifest hypo- or hyperthyreodism). Patients with comorbid personality disorders and other axis 1 disorders will also be excluded.

Design outcomes

Primary

Measure	Time frame
(1) with respect to group classification: a) to confirm whether those VOCs, derived significant from breath gas analysis in our pilot study, discriminate patients with acute depressive episodes (MDD) from healthy states in controls in a larger test and a validation sample. b) to identify further VOC signatures that might differentiate MDD from heathy controls, also with deep learning tools. (2) with respect to factors impacting breath gas signatures: a) to test the influence of antidepressant medication, since this is one of the main factors that need to be controlled for in clinical practice: i) Differences in VOCs at baseline between antidepressant-free patients and patients with antidepressants will be examined. ii) The effect of antidepressant therapy on VOCs will be analysed longitudinally in patients, who are antidepressant free at baseline and receive antidepressants during therapy. b) to investigate the effect of nutrition (both cross-sectionally and longitudinally). c) to examine the effects of hormones in females and the effect of physiology on the VOCs. (3) with respect to prediction of outcome: to examine if VOCs that discriminate between patients and controls can also predict the therapy response of single patients for at least the next four weeks for guideline driven treatment. (4) to explore the association between these VOCs and cortisol awakening response. (5) to perform quality control of teddlar bag sampling and to explore the underlying substances using GC-GC-TOF-MS	—

Measure

Time frame

(1) with respect to group classification: a) to confirm whether those VOCs, derived significant from breath gas analysis in our pilot study, discriminate patients with acute depressive episodes (MDD) from healthy states in controls in a larger test and a validation sample. b) to identify further VOC signatures that might differentiate MDD from heathy controls, also with deep learning tools. (2) with respect to factors impacting breath gas signatures: a) to test the influence of antidepressant medication, since this is one of the main factors that need to be controlled for in clinical practice: i) Differences in VOCs at baseline between antidepressant-free patients and patients with antidepressants will be examined. ii) The effect of antidepressant therapy on VOCs will be analysed longitudinally in patients, who are antidepressant free at baseline and receive antidepressants during therapy. b) to investigate the effect of nutrition (both cross-sectionally and longitudinally). c) to examine the effects of hormones in females and the effect of physiology on the VOCs. (3) with respect to prediction of outcome: to examine if VOCs that discriminate between patients and controls can also predict the therapy response of single patients for at least the next four weeks for guideline driven treatment. (4) to explore the association between these VOCs and cortisol awakening response. (5) to perform quality control of teddlar bag sampling and to explore the underlying substances using GC-GC-TOF-MS

—

Secondary

Measure	Time frame
Beck Depression Inventory (BDI)	—

Countries

Germany

Contacts

Public ContactThomas Frodl

Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Uniklinik RWTH Aachen

tfrodl@ukaachen.de02418089632

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026