tVNS for Depression

Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02562703

Enrollment

Registered

2015-09-29

Start date

2015-11-30

Completion date

2016-07-31

Last updated

2015-09-29

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

Conditions

Depressive Disorder

Brief summary

This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.

Interventions

DEVICETranscutaneous Vagus Nerve Stimulation

tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Inclusion criteria

1. patients between 18 and 69 years 2. patients with a diagnosis of depression according to the SCID 3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode) 4. agreement to participate in the study as recommended in the IC.

Exclusion criteria

1. patients with psychiatric indication for hospitalization 2. patients with psychiatric comorbidity 3. patients with a diagnosis of personality disorder 4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Design outcomes

Primary

Measure	Time frame	Description
• Hamilton Depressive Rating Scale version 17 items (HDRS-17)	Change from baseline in depressive symptoms at 2 weeks	This clinical trial has as primary objective to evaluate the effect of the tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.

Contacts

Primary ContactAlisson P Trevizol, MD

alisson.trevizol@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026