Epidural Stimulation for Resistant Depression Treatment

NCT02622633 | Unknown Phase 2

• 1 other identifier: 40803214.2.0000.0033
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the effectiveness and feasibility of using an implantable system that provides epidural electrical stimulation directly to the left prefrontal dorsolateral cortex (Brodmann area 9/46) in patients with chronic and refractory Depressive Disorder Major.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Change in Rating Scale Hamilton Depression

  assessment of severity of symptoms in depressed patients with primary depressive illness and monitoring changes due to treatment

  baseline - 12 weeks - 26 weeks

Secondary Outcomes (3)

• Change in Depression Scale Montgomery-Asberg Depression Rating Scale

  Baseline - 12 weeks -26 weeks

• Change in Scale of the SF-36

  Baseline - 12 weeks -26 weeks

• Frequency of Side Effects Scale - (UKU- Ugvalg is Kliniske Undersgelser)

  Baseline - 12 weeks - 26 weeks

Study Arms (2)

Stimulation

EXPERIMENTAL

One week after implantation of the device, participants randomized in this arm will receive continuous magnetic stimulation of high frequency (50Hz) with epidural electrode for 12 weeks. And then, the epidural electrode will be turned off for more 12 weeks in a crossover fashion.

Device: Epidural Electrode

Sham Stimulation

SHAM COMPARATOR

One week after implantation of the device, participants randomized in this arm will receive sham stimulation for 12 weeks and then continuous magnetic stimulation with epidural electrode of high frequency (50Hz) stimulation for more 12 weeks.

Device: Epidural Electrode

Interventions

Epidural Electrode DEVICE

Epidural electrode of high frequency (50Hz) stimulation in the dorsolateral prefrontal cortex.

Sham Stimulation; 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:

• Subjects must have failed to respond to at least four different trials with antidepressant at therapeutic doses for a period of at least six weeks, associated with specific psychotherapy during this period and/or use of ECT or VNS. The medication treatment for depression used at the moment of selection should remain unchanged for at least eight weeks after implantation and will not change during the study period. Possible needs therapeutic adjustments during the study will be managed with changes in parameter magnetic stimulation
• Patients should score at least 20 points on the Hamilton Rating Scale (Hamilton Depression Rating Scale-28 (HDRS))

You may not qualify if:

• Pregnancy
• Preexisting neurological disease including epilepsy
• Other psychiatric disorders except for anxiety disorders
• Less than 24 Mini-Mental or any other cognitive disorder
• Being with serious suicidal ideation
• Medical conditions that preclude surgery as judgment of the research team

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Rivadavio Amorim

Brasília, Federal District, 70910-900, Brazil

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 4, 2015
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

BR (1)