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TNS for Treating Major Depressive Disorder in the Elderly

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: NCT02562677
Recruitment Status : Unknown
Verified September 2015 by Pedro Shiozawa, Santa Casa Medical School.
Recruitment status was:  Not yet recruiting
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Pedro Shiozawa, Santa Casa Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Elderly Device: Transcutaneous Trigeminal Nerve Stimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACTIVE tNS
TNS 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 on the forehead just above the supraorbital foramen bilaterally. The study protocol will follow the rational of our previous trials with TNS.
Device: Transcutaneous Trigeminal Nerve Stimulation



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 elderly patients with moderate / severe depressive episode



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02562677


Contacts
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Contact: Alisson P Trevizol, MD alisson.trevizol@hotmail.com

Sponsors and Collaborators
Santa Casa Medical School
Publications of Results:
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Responsible Party: Pedro Shiozawa, Coordinator - Interdisciplinary Center for Clinical Neuromodulation, Santa Casa Medical School
ClinicalTrials.gov Identifier: NCT02562677    
Other Study ID Numbers: TNS for Elderly
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms