tVNS for Depression

Depressive Disorder Clinical Trial

Official title:

Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02562703
• Other study ID #: tVNS
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 25, 2015
• Last updated: September 25, 2015
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Santa Casa Medical School
• Contact: Alisson P Trevizol, MD
• Email: alisson.trevizol[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa Medical School

References & Publications (3)

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 Ju — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No