Electrical Stimulation in Patients With Unipolar Major Depression

NCT02239822 | Completed Phase 2 DMC

• 1 other identifier: 271/2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Double Blinded Randomized Trial of eTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of eTNS (external trigeminal nerve stimulation) 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

Keywords

Electrodes, Implanted; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (1)

• Identify a efficacy of eTNS 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.

  48 weeks

Secondary Outcomes (3)

• Identify the tolerability of eTNS stimulation

  48 weeks

• Identify the long-term recurrence rate of eTNS therapy

  48 weeks

• Identify the duration of the placebo effect

  48 weeks

Study Arms (2)

Active Stimulation

ACTIVE COMPARATOR

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

Procedure: Stimulation of the trigeminal nerve (active stimulation)

Placebo Stimulation

PLACEBO COMPARATOR

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)

Interventions

Stimulation of the trigeminal nerve (active stimulation) 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. the duration of the open label trial will be more 24 weeks.

Also known as: Electrical Stimulation

Active Stimulation

Placebo stimulation of the trigeminal nerve (placebo) 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.

Also known as: Sham Eletrical Stimulation

Placebo Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

Depression

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Alessandra Gorgulho, MD, MSc

  HOSPITAL DO CORAÇÃO

  PRINCIPAL INVESTIGATOR

• Antonio De Salles, M.D., Ph.D.

  HOSPITAL DO CORAÇÃO

  PRINCIPAL INVESTIGATOR

• Otavio Berwanger, MD,PhD

  HOSPITAL DO CORAÇÃO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 15, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

BR (1)