The Effects of Trigeminal Nerve Stimulation (TNS) for the Treatment of Major Depressive Disorder: a Phase II, Randomized, Sham Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 44
- Locations
- 2
- 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older 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 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 Outcomes
- Montreal Cognitive Assessment (MOCA)(Change from baseline in cognitive functioning at 2 weeks)
Investigators
Pedro Shiozawa
Pedro Shiozawa, Coordinator, Laboratory of Clinical Neuromodulation, Principal Investigator
Faculdade de Ciências Médicas da Santa Casa de São Paulo