TNS for Treating Major Depressive Disorder in the Elderly

Santa Casa Medical School10 enrolled

Overview

This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder Elderly

Interventions

Transcutaneous Trigeminal Nerve StimulationDEVICE

Eligibility

Sex: ALLMin age: 65 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. patients between 65 and 99 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 Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in elderly 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

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