tVNS for Depression

Santa Casa Medical School40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder

Interventions

Transcutaneous Vagus Nerve StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

• Hamilton Depressive Rating Scale version 17 items (HDRS-17)

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.

Time frame: Change from baseline in depressive symptoms at 2 weeks

Central Contacts

Alisson P Trevizol, MD

CONTACT

alisson.trevizol@hotmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.