NCT02239809

Electrical Stimulation in Patients With Unipolar Major Depression

Double Blinded Randomized Trial of sTNS as Adjuvant Treatment for Major Unipolar Depressive Disorder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2014-09-15
• Last updated: 2016-09-29

Locations

1 site across 1 country: Brazil