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

The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02105376

Enrollment

Registered

2014-04-07

Start date

2014-05-31

Completion date

Unknown

Last updated

2015-05-05

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

Conditions

Depressive Symptoms

Keywords

depression, cranial nerve stimulation, trigeminal stimulation

Brief summary

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.

Interventions

DEVICETrigeminal Nerve Stimulation (TNS)

Trigeminal Nerve Stimulation (TNS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 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 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.

Secondary

Measure	Time frame	Description
Montreal Cognitive Assessment (MOCA)	Change from baseline in cognitive functioning at 2 weeks	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

Countries

Brazil

Contacts

Primary ContactPedro Shiozawa, MD

pedroshiozawa@gmail.com55 11 34662100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026