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TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

NCT02105376 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-05-05

No results posted yet for this study

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.

Conditions

  • Depressive Symptoms

Interventions

DEVICE

Trigeminal Nerve Stimulation (TNS)

Trigeminal Nerve Stimulation (TNS)

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    collaborator OTHER

  • Santa Casa Medical School

    lead OTHER

Principal Investigators

  • Quirino Cordeiro, MD, PhD · Santa Casa Medical School

  • Pedro Shiozawa, MD · Santa Casa Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02105376 on ClinicalTrials.gov