NCT02562703

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

September 25, 2015

Last Update Submit

September 25, 2015

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • • 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.

    Change from baseline in depressive symptoms at 2 weeks

Study Arms (2)

ACTIVE tVNS

ACTIVE COMPARATOR

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.

Device: Transcutaneous Vagus Nerve Stimulation

SHAM tVNS

SHAM COMPARATOR

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

Device: Transcutaneous Vagus Nerve Stimulation

Interventions

Transcutaneous Vagus Nerve StimulationDEVICE

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.

ACTIVE tVNSSHAM tVNS

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26358492RESULT

  • 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.

    PMID: 25150403RESULT

  • 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.

    PMID: 23773978RESULT

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Central Study Contacts

Alisson P Trevizol, MD

CONTACT

alisson.trevizol@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator - Interdisciplinary Center for Clinical Neuromodulation

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 29, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

September 29, 2015

Record last verified: 2015-09