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Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

ConditionsDepressive DisorderBipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMax-Planck-Institute of Psychiatry

About this trial

Invasive vagus nerve stimulation (VNS) is an approved treatment of treatment-resistant depression (TRD) in Europe and in USA. Because of the associated possible surgical complications as well as side effects, invasive VNS is applied limitedly in the treatment of depression. Transcutaneous auricular VNS (tVNS), on the other hand, is a non-invasive alternative to traditional invasive VNS. tVNS is still considered an experimental treatment for depression. This is due to the limited high-quality evidence from randomized clinical studies, the not yet fully understood biological mechanisms of action, along with overall limited knowledge about the optimal stimulation parameters. To address these issues, the AddVNS study was initiated. The AddVNS study intends to recruit n=86 patients of the Max Planck Institute of Psychiatry with depression. The patients participating in the AddVNS study are going to receive either tVNS or sham tVNS for a period of 6 weeks. The primary objective of the study is to identify biological, psychological, socio-economic, and clinical biomarkers associated with treatment progression and response to treatment in patients with depression undergoing tVNS. To achieve this, an exploratory design with an assessment of many different parameters including psychophysiology, imaging, blood-based multi-omics, microbiome, psychometrics and neuropsychology will be used.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-65 years, legally competent and able to provide informed consent;

diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11;

signed informed consent documents for the AddVNS study;

signed informed consent and participation in the biobanking project of MPIP;

Disqualifiers

age < 18 years or age > 65 years;

pregnancy or planning to get pregnant during the study period, breastfeeding;

legal supervision;

pervasive developmental disorders and/or intellectual disability;

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcutaneous auricular vagus nerve stimulation

    Device

    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.

  • sham transcutaneous auricular vagus nerve stimulation

    Device

    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

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: tVNS-arm (transcutaneous auricular vagus nerve stimulation)Experimental treatment 1 intervention
Group B: sham tVNS-arm (sham transcutaneous auricular vagus nerve stimulation)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in pupillometry

Pupil diameter associated with the clinical response to tVNS

Time frame
Baseline, week 3, week 6
2

Change from baseline in 3-channel ECG

3-channel ECG associated with the clinical response to tVNS

Time frame
Baseline, week 3, week 6
3

Change from baseline in skin conductance level

Skin conductance level associated with the clinical response to tVNS

Time frame
Baseline, week 3, week 6
4

Change from baseline in photoplethysmography

Photoplethysmography associated with the clinical response to tVNS

Time frame
Baseline, week 3, week 6

Secondary outcomes

1

Change from baseline in the Hamilton Depression Rating Scale (HAM-D)

The HAM-D measures the presence and severity of depression. Each of the items is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the HAM-D score is ≤ 7 points

Time frame
Baseline, week 3, week 6
2

Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS)

The MADRS measures the presence and severity of depression. Each of the terms is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the MADRS score falls short of 12 points

Time frame
Baseline, week 3, week 6
3

Change from baseline in the Global Assessment of Functioning (GAF)

The GAF approximates the level of symptom burden and psychosocial as well as occupational functioning in daily life. It is tailored primarily to psychiatric patients. It is rated from 0 to 100 by a trained clinician. The GAF score is a continuous variable and allows to estimate symptom reduction and functional assessment from a foreign rater perspective

Time frame
Baseline, week 3, week 6
4

Change from baseline in the Beck-Depression-Inventory II (BDI-II)

The BDI-II measures the presence and severity of depression symptoms on a mostly psychological and partially somatic level. Each of the 21 items is rated by the patient and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the BDI-II score is ≤ 10 points

Time frame
Weekly up to week 6, week 12, week 18

Other outcomes

1

Identification of clinical predictors of treatment response namely maladaptive personality traits measured by the German version of the Personality Inventory for DSM-5 and ICD-11 - brief form -version 1.1 (self-rating)

Lead to identification of maladaptive personality traits, no score on a scale.

Time frame
Baseline
2

Identification of clinical predictors of treatment response namely maladaptive personality traits measured by the Levels of Personality Functioning Scale-Brief Form 2.0 (self-rating)

Lead to identification of maladaptive personality traits, no score on a scale.

Time frame
Baseline
3

Sociodemographic variables (age, gender, marital status, income, education, occupation, family history of migration)

Sociodemographic variables as covariables for analysis of treatment response

Time frame
Baseline
4

Medical history (psychiatric history, somatic medical history, family history, substance use history, medication history)

Medical history as covariable for analysis of treatment response

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Max-Planck-Institute of Psychiatry

Lead sponsor

Source ClinicalTrials.gov
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