tVNS for Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ACTIVE tVNS

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.

Group Type ACTIVE_COMPARATOR

Transcutaneous Vagus Nerve Stimulation

Intervention Type DEVICE

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.

SHAM tVNS

tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.

Group Type SHAM_COMPARATOR

Transcutaneous Vagus Nerve Stimulation

Intervention Type DEVICE

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.

Interventions

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Transcutaneous Vagus Nerve Stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No