Electrical Stimulation in Patients With Unipolar Major Depression

NCT ID: NCT02239809

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Stimulation

Patients assigned to active stimulation arm will receive electrical stimulation during the study.

Group Type: ACTIVE_COMPARATOR

Stimulation of the trigeminal nerve (active stimulation)

Intervention Type: PROCEDURE

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.

Placebo 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.

Group Type: PLACEBO_COMPARATOR

Placebo stimulation of the trigeminal nerve (placebo)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Electrical Stimulation; Sham Eletrical Stimulation

Eligibility Criteria

Inclusion Criteria

• Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview and legally capacitated to sign the informed consent for participation in the study;
• A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2;
• A history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
• Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
• Patients with appropriate support to be compliant with the study protocol.

Exclusion Criteria

• Patient is mentally or legally incapacitated, unable to give informed consent.
• Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
• Patients currently receiving more than six medications for treatment of MDD;
• Patients with exposure to ECT or rTMS or any investigational treatment (for any disorder) within the past 6 months;
• Prior VNS and/or DBS therapy (lifetime);
• Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis;
• Current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
• Other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandra Gorgulho, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Antonio De Salles, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração

Otavio Berwanger, MD,PhD

Role: STUDY_DIRECTOR

Hospital do Coração

Locations

Hospital do Coracao

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

239/2012

Identifier Type: -

Identifier Source: org_study_id