TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

Santa Casa Medical School44 enrolled

Overview

This is a phase II, randomized, sham controlled, clinical trial. 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 patients with moderate / severe depressive episode.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Symptoms

Interventions

Trigeminal Nerve Stimulation (TNS)DEVICE

Trigeminal Nerve Stimulation (TNS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 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.

Locations (1)

Centro de Atencao Integrada à Saúde Mental

São Paulo, São Paulo, Brazil

RECRUITING

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 patients with moderate / severe depressive episode.

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

Secondary Outcomes

Montreal Cognitive Assessment (MOCA)

We also use the questionnaire Montreal Cognitive Assessment (MOCA) for assessment of cognitive function, considering the level of consciousness and global functioning in order to compare your score with estimates made by other instruments. It will also serve to assess possible cognitive damage and whether there are improvements in some specific cognitive functions with treatment

Time frame: Change from baseline in cognitive functioning at 2 weeks

Central Contacts

Pedro Shiozawa, MD

CONTACT

55 11 34662100 pedroshiozawa@gmail.com

Data from ClinicalTrials.gov

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