Effect of TNS for Major Depressive Disorder in the Elderly: a Phase II Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 10
- Primary Endpoint
- Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 99 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients between 65 and 99 years
- •patients with a diagnosis of depression according to the SCID
- •score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
- •agreement to participate in the study as recommended in the IC.
Exclusion Criteria
- •patients with psychiatric indication for hospitalization
- •patients with psychiatric comorbidity
- •patients with a diagnosis of personality disorder
- •presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Pedro Shiozawa
Coordinator - Interdisciplinary Center for Clinical Neuromodulation
Santa Casa Medical School