tVNS for Depression

Phase 1

• Conditions: Depressive Disorder
• Interventions: Device: Transcutaneous Vagus Nerve Stimulation

• Registration Number: NCT02562703
• Lead Sponsor: Santa Casa Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-25
• Last Update Submitted: 2015-09-25
• Study First Posted: 2015-09-29
• Last Update Posted: 2015-09-29
• Study Start: 2015-11
• Primary Completion: 2016-02
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM tVNS	Transcutaneous Vagus Nerve Stimulation	tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.
ACTIVE tVNS	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.

Primary Outcome Measures

Name	Time	Method
• 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 tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.