Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105376
Recruitment Status : Unknown
Verified May 2015 by Pedro Shiozawa, Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Recruitment status was:  Recruiting
First Posted : April 7, 2014
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Information provided by (Responsible Party):
Pedro Shiozawa, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Device: Trigeminal Nerve Stimulation (TNS) Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2014
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trigeminal Nerve Stimulation (TNS)

TNS active group

TNS will be applied by the external simulator EMS400. The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 200 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia (approximately 0.5-2mA). The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed on the forehead just above the supraorbital foramen bilaterally.

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

Placebo Comparator: Sham

TNS sham

The placebo intervention will consist of an initial stimulation until a mild paresthesia is achieved, and then turn off the machine after 60 seconds, after which period there is a tendency of reduction natural feeling secondary to skin sensitization paresthesia.




Primary Outcome Measures :
  1. Hamilton Depressive Rating Scale version 17 items (HDRS-17) [ Time Frame: Change from baseline in depressive symptoms at 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Montreal Cognitive Assessment (MOCA) [ Time Frame: Change from baseline in cognitive functioning at 2 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105376


Contacts
Layout table for location contacts
Contact: Pedro Shiozawa, MD 55 11 34662100 pedroshiozawa@gmail.com

Locations
Layout table for location information
Brazil
Centro de Atencao Integrada à Saúde Mental Recruiting
Sao Paulo, SP, Brazil, 04017030
Contact: Pedro Shiozawa, MD    55 11 34662100    pedroshiozawa@gmail.com   
Principal Investigator: Pedro Shiozawa, MD         
Sub-Investigator: Quirino Cordeiro, MD, PhD         
Sponsors and Collaborators
Santa Casa Medical School
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Layout table for investigator information
Study Director: Quirino Cordeiro, MD, PhD Santa Casa Medical School
Principal Investigator: Pedro Shiozawa, MD Santa Casa Medical School

Publications:
Layout table for additonal information
Responsible Party: Pedro Shiozawa, Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT02105376     History of Changes
Other Study ID Numbers: TNS_depression
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Keywords provided by Pedro Shiozawa, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
depression
cranial nerve stimulation
trigeminal stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms