Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- • Hamilton Depressive Rating Scale version 17 items (HDRS-17)
Study Overview
Brief Summary
This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients between 18 and 69 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 tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in 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