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

Santa Casa Medical School0 sites40 target enrollmentNovember 2015

ConditionsDepressive Disorder

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Depressive Disorder
Sponsor: Santa Casa Medical School
Enrollment: 40
Primary Endpoint: • Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

July 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santa Casa Medical School

Responsible Party

Principal Investigator

Pedro Shiozawa

Coordinator - Interdisciplinary Center for Clinical Neuromodulation

Santa Casa Medical School

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•patients with psychiatric indication for hospitalization
•patients with psychiatric comorbidity
•patients with a diagnosis of personality disorder
•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)

Time Frame: 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.