A Phase 2 interventional study of Stimulation of the trigeminal nerve (active stimulation) and Placebo stimulation of the trigeminal nerve (placebo) in Depression, sponsored by Hospital do Coracao. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-29.
Sponsored by Hospital do Coracao · Phase 2, Interventional, and Treatment
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 20 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hospital do Coracao is the lead sponsor of 66 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Patients assigned to active stimulation arm will receive electrical stimulation during the study.
Procedure: Stimulation of the trigeminal nerve (active stimulation)
Patients assigned to the placebo arm did not receive stimulation electrical stimulation for 24 weeks. After this period the participants randomized to sham stimulation will be moved to the active stimulation and will be followed until study completion.
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. 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.
Also known as: Electrical 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. 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.
Also known as: Sham Eletrical Stimulation
Identify a efficacy of sTNS of the V1 branch of the trigeminal nerve
We will use the Hamilton Rating Scale for Depression (HRSD) 17 scores as the main outcome measure to assess the efficacy of sTNS of the V1 branch of the trigeminal nerve as adjunctive treatment for MDD.
Time frame: 12 months
Identify the tolerability of sTNS stimulation
Tolerability will be evaluated by the records of adverse effects observed during the randomized, open stimulation. We will apply the Ugvalg for Kliniske Undersgelser (UKU) scale at all visits for all patients and to compare scores between groups. Adverse events will be categorized using the MedDRA Medical Dictionary for Regulatory Activities. Complications reported by active and sham stimulation groups will be compared. The complication risk will be calculated based on the overall study duration.
Time frame: 12 months
Identify the long-term recurrence rate of sTNS therapy
We will calculate the recurrence rate of all participants at the end of the open label prospective follow-up. Recurrence is defined as return of HAM-17 scores equal to or superior to the original, after the patient has lodged during partial response (20% decrease of the initial score) or complete response (50% decrease of the initial score).
Time frame: 12 months
Identify the duration of the placebo effect
To evaluate the duration of the placebo effect in participants randomized to sham stimulation during the initial 12 weeks of the trial. The mean, median and the standard deviation of the interval time to recurrence will be calculated on placebo stimulation.
Time frame: 12 months
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hospital do Coracao