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tVNS for Depression

Primary Purpose

Depressive Disorder

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Transcutaneous Vagus Nerve Stimulation
Sponsored by
Santa Casa Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    ACTIVE tVNS

    SHAM tVNS

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    • Hamilton Depressive Rating Scale version 17 items (HDRS-17)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2015
    Last Updated
    September 25, 2015
    Sponsor
    Santa Casa Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02562703
    Brief Title
    tVNS for Depression
    Official Title
    Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Santa Casa Medical School

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ACTIVE tVNS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    SHAM tVNS
    Arm Type
    Sham Comparator
    Arm Description
    tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous Vagus Nerve Stimulation
    Intervention Description
    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 Measure Information:
    Title
    • Hamilton Depressive Rating Scale version 17 items (HDRS-17)
    Description
    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.
    Time Frame
    Change from baseline in depressive symptoms at 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients between 18 and 69 years patients with a diagnosis of depression according to the SCID score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode) agreement to participate in the study as recommended in the IC. Exclusion Criteria: patients with psychiatric indication for hospitalization patients with psychiatric comorbidity patients with a diagnosis of personality disorder presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alisson P Trevizol, MD
    Email
    alisson.trevizol@hotmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26358492
    Citation
    Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.
    Results Reference
    result
    PubMed Identifier
    25150403
    Citation
    Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
    Results Reference
    result
    PubMed Identifier
    23773978
    Citation
    Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.
    Results Reference
    result

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    tVNS for Depression

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