Modulation of reward responsiveness, gut microbial composition and immune response in major depressive disorder through transcutaneous vagus nerve stimulation (MODULATE-DEPRESSION)

Modulation of reward responsiveness, gut microbial composition and immune response in major depressive disorder through transcutaneous vagus nerve stimulation (MODULATE-DEPRESSION) - MODULATE-DEPRESSION

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024823

Enrollment

150

Registered

2021-05-20

Start date

2021-05-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F32 F33

Interventions

Group 1: TRIAL A: transcutaneous vagus nerve stimulation (device: NEMOS, tvns technologies), acute stimulation (~2h)

randomized on day 1 and 2 to either verum or sham and vice versa

each participant undergoes both phases

stimulation site: cymba conchae, earlobe. Group 2: TRIAL B: sham Stimulation (Gerät: NEMOS, tvns technologies), transkutane Sham Stimulation an der Cmybae Conchae, 4 Stunden täglich, 5 Tage die Woche,

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for controls: • Age:18-65 years • Ability to give consent Inclusion criteria for patients: • Age:18-65 years • Presence of a depressive Episode, both first episode or an an episode in the context of a know recurrent depressive disorder with or without psychotic symptoms (according to ICD 10: F32.0, F32.1, F32.2, F32.3, F33.2, F33.3) • Ability to give consent

Exclusion criteria

Exclusion criteria: Exclusion criteria for controls: • History of - psychiatric diseases - neurological, autoimmune, rheumatological, neoplastic, dermatological or metabolic disorders - acute infection • Pregnancy and lactation • BMI>30 kg/m2 Exclusion criteria for patients: • History of - psychiatric disease not defined in the inclusion criteria: dementia, bipolar disorder, schizophrenic psychosis, substance abuse disorder - neurological, autoimmune, rheumatological, neoplastic, dermatological or metabolic disorders - skin disseases - acute infection • Clearly organic or substance-induced cause of depression • Pregnancy and lactation • BMI > 30 kg/m2

Design outcomes

Primary

Measure	Time frame
Changes of acute and long-term application of tVNS on reward responsiveness, inflammatory profile and changes of the and gut microbiome profile after acute and long-term application of tVNS. Changes in depressive symptoms after long-term application of tVNS (as measured with the BDI-II and MADRS scales and FERT task). Changes will be assessed by outcomes of a computerized task (for reward responsiveness), inflammatory markers (measured with ELISA or comparable), and gut microbiome profile (measured by 16S Sequencing or comparable).	—

Measure

Time frame

Changes of acute and long-term application of tVNS on reward responsiveness, inflammatory profile and changes of the and gut microbiome profile after acute and long-term application of tVNS. Changes in depressive symptoms after long-term application of tVNS (as measured with the BDI-II and MADRS scales and FERT task). Changes will be assessed by outcomes of a computerized task (for reward responsiveness), inflammatory markers (measured with ELISA or comparable), and gut microbiome profile (measured by 16S Sequencing or comparable).

—

Secondary

Measure	Time frame
• Changes in basal heart-rate variability and heart rate variability in response to stress after acute and long-term application of tNVS (measured by EKG) • Correlation between changes of reward responsiveness, anhedonia, perceived stress, inflammatory profile and gut-microbiome composition.	—

Countries

Germany

Contacts

Public ContactSharmili Edwin Thanarajah

Goethe Universität Frankfurt

sharmili.edwinthanarajah@kgu.de+49 (0)69 6301 83348

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026