TNS for Treating Major Depressive Disorder in the Elderly

Major Depressive Disorder Clinical Trial

Official title:

Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02562677
• Other study ID #: TNS for Elderly
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 25, 2015
• Last updated: September 25, 2015
• Start date: October 2015
• Est. completion date: February 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, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

1. patients between 65 and 99 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Elderly
• Major Depressive Disorder

Intervention

Device:
• Transcutaneous Trigeminal Nerve Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa Medical School

References & Publications (2)

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

Shiozawa P, Silva ME, Carvalho TC, Cordeiro Q, Brunoni AR, Fregni F. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. 2014 Jul;72(7):542-7. Review. — 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 Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in elderly patients with moderate / severe depressive episode	Change from baseline in depressive symptoms at 2 weeks ]	No