Clinical trial NCT02105376: TNS for Major Depressive Disorder: a Phase II Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Depressive Symptoms
Keywords: depression
cranial nerve stimulation
trigeminal stimulation
Lead sponsor: Santa Casa Medical School
Sponsor class: OTHER
Collaborators: name: Faculdade de Ciências Médicas da Santa Casa de São Paulo
First posted: 2014-04-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton Depressive Rating Scale version 17 items (HDRS-17)
timeFrame: Change from baseline in depressive symptoms at 2 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Change from baseline in cognitive functioning at 2 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Atencao Integrada à Saúde Mental
state: SP
Study officials:
affiliation: Santa Casa Medical School
name: Quirino Cordeiro, MD, PhD
role: STUDY_DIRECTOR
affiliation: Santa Casa Medical School
name: Pedro Shiozawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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. No abstract available.
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.
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.