TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

Depressive Symptoms Clinical Trial

Official title:

The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02105376
• Other study ID #: TNS_depression
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 10, 2014
• Last updated: May 3, 2015
• Start date: May 2014

Study information

• Verified date: May 2015
• Source: Santa Casa Medical School
• Contact: Pedro Shiozawa, MD
• Phone: 55 11 34662100
• Email: pedroshiozawa[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Agência Nacional de Vigilância Sanitária
• 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 the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms

Intervention

Device:
• Trigeminal Nerve Stimulation (TNS)
Trigeminal Nerve Stimulation (TNS)

Locations

Country	Name	City	State
Brazil	Centro de Atencao Integrada à Saúde Mental	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Santa Casa Medical School	Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

DeGiorgio CM, Fanselow EE, Schrader LM, Cook IA. Trigeminal nerve stimulation: seminal animal and human studies for epilepsy and depression. Neurosurg Clin N Am. 2011 Oct;22(4):449-56, v. doi: 10.1016/j.nec.2011.07.001. Review. — View Citation

Riva-Posse P, Hermida AP, McDonald WM. The role of electroconvulsive and neuromodulation therapies in the treatment of geriatric depression. Psychiatr Clin North Am. 2013 Dec;36(4):607-30. doi: 10.1016/j.psc.2013.08.007. Epub 2013 Oct 6. Review. — View Citation

Schrader LM, Cook IA, Miller PR, Maremont ER, DeGiorgio CM. Trigeminal nerve stimulation in major depressive disorder: first proof of concept in an open pilot trial. Epilepsy Behav. 2011 Nov;22(3):475-8. doi: 10.1016/j.yebeh.2011.06.026. Epub 2011 Aug 4. — View Citation

Shiozawa P, Cordeiro Q, Fregni F, Brunoni AR. Is sertraline plus transcranial direct current stimulation the future of effective depression treatment? J Comp Eff Res. 2013 May;2(3):213-5. doi: 10.2217/cer.13.28. — View Citation

Vuilleumier P, Sander D, Baertschi B. Changing the brain, changing the society: clinical and ethical implications of neuromodulation techniques in neurology and psychiatry. Brain Topogr. 2014 Jan;27(1):1-3. doi: 10.1007/s10548-013-0325-7. Epub 2013 Oct 25. — 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 patients with moderate / severe depressive episode.	Change from baseline in depressive symptoms at 2 weeks	No
Secondary	Montreal Cognitive Assessment (MOCA)	We also use the questionnaire Montreal Cognitive Assessment (MOCA) for assessment of cognitive function, considering the level of consciousness and global functioning in order to compare your score with estimates made by other instruments. It will also serve to assess possible cognitive damage and whether there are improvements in some specific cognitive functions with treatment	Change from baseline in cognitive functioning at 2 weeks	No