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Electrical Stimulation in Patients With Unipolar Major Depression

NCT02239809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-09-29

No results posted yet for this study

Summary

Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of an implantable sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).

Conditions

Interventions

PROCEDURE

Stimulation of the trigeminal nerve (active stimulation)

Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study. Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study. The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.

PROCEDURE

Placebo stimulation of the trigeminal nerve (placebo)

Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. Patients of the placebo group will be implanted with a lead in the V1 branch of the trigeminal nerve, but will not receive stimulation. After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study. Participants randomized to placebo stimulation will be shifted to active stimulation and will be followed-up until completion of the study. The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alessandra Gorgulho, MD, MSc · Hospital do Coracao

  • Antonio De Salles, M.D., Ph.D. · Hospital do Coração

  • Otavio Berwanger, MD,PhD · Hospital do Coração

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT02239809 on ClinicalTrials.gov