Electrical Stimulation in Patients With Unipolar Major Depression

"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."

"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."