Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

NARecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

March 17, 2030

Study Completion Date

March 17, 2030

Conditions
Depressive DisorderBipolar Disorder
Interventions
DEVICE

transcutaneous auricular vagus nerve stimulation

Half of the patients are randomized to the arm receiving transcutaneous auricular vagus nerve stimulation for a period of six weeks. Transcutaneous auricular vagus nerve stimulation will be carried out as an adjuvant, i.e. in addition to the regular treatment of the participants. The intervention will take place three times a day from Monday to Friday. Each of the three daily sessions is going to last 30-60 minutes, depending on patient tolerance.

DEVICE

sham transcutaneous auricular vagus nerve stimulation

Half of the patients are randomized to the arm receiving sham transcutaneous auricular vagus nerve stimulation for a period of six weeks. Sham transcutaneous auricular vagus nerve stimulation will be carried out as an adjuvant, i.e. in addition to the regular treatment of the participants. The intervention will take place three times a day from Monday to Friday. Each of the three daily sessions is going to last 30-60 minutes. The procedures for sham tVNS will be identical to tVNS, with the only exception that the sham tVNS will be performed with no current output

Trial Locations (1)

80804

RECRUITING

Max Planck Institute of Psychiatry, Munich

All Listed Sponsors
lead

Max-Planck-Institute of Psychiatry

OTHER