Elderly, Major Depressive Disorder
Conditions
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.
Interventions
DEVICETranscutaneous Trigeminal Nerve Stimulation
Sponsors
Santa Casa Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depressive Rating Scale version 17 items (HDRS-17) | 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 |
Contacts
Primary ContactAlisson P Trevizol, MD
Outcome results
None listed